Getinge Washer Disinfector 46 Series User Manual Rating: 6,6/10 6210 votes
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Getinge 46-series Washer-Disinfectors offer a large chamber size with a minimal external footprint giving you a higher throughout without increasing floor space. The Getinge 46-5 model has space for up to five levels of instrument wash carts. Getinge 46-4 has space for up to four levels of wash carts. Getinge 46-series washer-disinfectors combine hygienic and ergonomic solutions with well-proven technology for maximum user safety. Choose between two, four and five levels, depending on the type and quantity of items you need to process. Sep 05, 2017 Get getinge 46 series washer manual PDF file for free from our online library. GETINGE 46 SERIES WASHER MANUAL. The subject of this eBook is focused on GETINGE 46 SERIES WASHER MANUAL, however it. A reliable and efficient washer-disinfector, with suitable accessories to meet your demands for up to 10 DIN trays. Getinge 86-series A smarter range of washer-disinfectors for high-throughput reprocessing.
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| GETINGE DISINFECTION AB GETINGE 46-SERIES WASHER DISINFECTOR | Back to Search Results |
| | Model Number 46-4 | | Device Problems Fire; Smoking | | Event Date 08/13/2013 | | Event Type Malfunction | | Event Description | Smoke/fire was observed coming from a getinge model 46-4 washer disinfector during use. The washer was approx 35-40 minutes into a 70 minute cycle when staff observed smoke/fire. The user's turned off the power to the unit and sprayed with a dry powder extinguisher. | | Manufacturer Narrative | Device was evaluated remotely (not returned to manufacturer) via investigation reports and photographs from getinge (b)(4). , a service unit located in (b)(4). It was concluded that the overheat protection system failed/delayed response to an overheat condition. A voluntary device correction of getinge model 46-4 washer disinfectors was reported to u. S. Fda on (b)(4) 2013 (recall number not yet assigned). This correction was initiated to address two conditions. A potential trigger for overheating; (root cause) - inadequate overheat protection system component. A component (shunt trip) selected for the overheat protection system does not meet the required parameters (control voltage) where/when overheating occurs. The correction entails - inspecting the setting of a software function that can be utilized during servicing of a unit to skip wash phases. This is a password protected function but if left in the enabled state, a user can inadvertently activate the heating element with no water in the chamber. The device correction action includes inspecting that this function is not enabled. The installation of a newer design of overheat protection system that utilizes a heating element with integral thermal fuses that meet the required overheat parameters. Recall number not yet assigned. | | Search Alerts/Recalls |
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Getinge Washer Disinfector Manual
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Getinge Instrument Washer
Getinge Service Manuals
| Type of Device | WASHER DISINFECTOR |
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| Manufacturer (Section D) | | GETINGE DISINFECTION AB | | ljungadalsgatan 11 | | vaxjo 351 15 | | SW 351 15 |
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| Manufacturer (Section G) | | GETINGE DISINFECTION AB | | ljungadalsgatan 11 | | vaxjo 351 15 | | SW 351 15 |
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| Manufacturer Contact | | ann wheeler, us agent | | 1777 e henrietta rd | | rochester , NY 14623 | | 5852725036 |
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| MDR Report Key | 3368406 |
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| Report Number | 9616031-2013-00004 |
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| Device Sequence Number | 1 |
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| Product Code | MDZ |
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| Report Source | Manufacturer |
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| Source Type | Company Representative |
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| Reporter Occupation |
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| Remedial Action | Repair |
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| Type of Report | Initial |
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| Report Date | 08/14/2013 |
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| 1 Device Was Involved in the Event |
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| 0 PatientS WERE Involved in the Event: |
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| Date FDA Received | 09/13/2013 |
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| Is This An Adverse Event Report? | No |
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| Is This A Product Problem Report? | Yes |
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| Device Operator |
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| Device MODEL Number | 46-4 |
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| Was Device Available For Evaluation? | No |
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| Is The Reporter A Health Professional? | Yes |
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| Event Location | Hospital |
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| Date Manufacturer Received | 08/14/2013 |
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| Was Device Evaluated By Manufacturer? | No |
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| Is The Device Single Use? | No |
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| Is this a Reprocessed and Reused Single-Use Device? | No |
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| Type of Device Usage | Invalid Data |
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