MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-08-22 for GETINGE 46-SERIES 46-4 manufactured by Getinge Disinfection Ab.
[15198329]
Smoke was observed coming from a getinge model 46-4 washer disinfector during use. The customer shut off the unit. No injuries or damage to the facility have been reported.
Patient Sequence No: 1, Text Type: D, B5
[15603493]
The device eval is currently in-progress. A voluntary device correction of getinge model46-4 water disinfectors was reported to us fda on 07/26/2013. This correction was initiated to address a software function that can be utilized during servicing of the unit. This is a password protected function but if left in the enabled state, a user could inadvertently activate the heating element without water in the chamber which could lead to an overheat condition. The device correction actions include inspecting that this function is not enabled and to installed a heating element with integral thermostat to address the delayed overheat protection. The incident subject of this mdr is still being investigated to determine its cause and to evaluate if any additional corrective actions are required as a result of this incident. No flame was reported in this instance though electrical wiring and components were damaged in the washer disinfector. No damage to the facility or injury to individuals were reported. A f/u mdr will be submitted at the conclusion of this incident investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616031-2013-00003 |
| MDR Report Key | 3370958 |
| Report Source | 06,07 |
| Date Received | 2013-08-22 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-07-22 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2013-11-19 |
| 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 | 351 15 |
| Single Use | 3 |
| 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 | 2013-08-22 |
| 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 | 2013-08-22 |