MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-07-17 for GETINGE 46-SERIES 46-4 manufactured by Getinge Disinfection Ab.
[15202797]
The fire alarms went off at 15:30 on (b)(6) 2010. The hospital used the washer last approx 21:00 (b)(6) 2010. No other detail of the report is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[15787728]
Due to an incident resulting in mdr #9616031-2013-00001, a retrospective review of similar complaints identified this incident having occurred with no mdr submitted. The device investigation concluded that the heating element was activated without water in the chamber and that the overheat protection failed. A correction of affected 46-4 washer-disinfectors was initiated on (b)(6) 2013 and report to fda in preparation. The report of voluntary correction will be submitted on the agency by or prior to (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616031-2013-00002 |
| MDR Report Key | 3264606 |
| Report Source | 99 |
| Date Received | 2013-07-17 |
| Date of Report | 2013-07-17 |
| Date of Event | 2010-08-14 |
| Date Mfgr Received | 2010-08-14 |
| Device Manufacturer Date | 2010-08-25 |
| Date Added to Maude | 2013-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN WHEELER(US AGENT) |
| Manufacturer Street | 1777 E HENRIETTA RD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5852725036 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 |
| Manufacturer City | VAXJO 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GETINGE 46-SERIES |
| Generic Name | WASHER DISINFECTOR |
| Product Code | MDZ |
| Date Received | 2013-07-17 |
| Model Number | 46-4 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO 35115 SW 351 15 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-17 |