MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-13 for GETINGE 46-SERIES 46-4 manufactured by Getinge Disinfection Ab.
[20109057]
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.
Patient Sequence No: 1, Text Type: D, B5
[20482096]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616031-2013-00004 |
| MDR Report Key | 3368406 |
| Report Source | 07 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-08-13 |
| Date Mfgr Received | 2013-08-14 |
| Date Added to Maude | 2013-09-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | 351 15 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 2013-09-13 |
| Model Number | 46-4 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-09-13 |