MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-10-02 for GETINGE 9125 UNK manufactured by Getinge Disinfection Ab.
[2789313]
During the installation of a waster disinfector and after applying power to the washer the service rep noticed smoke at the ground connection. The service rep observed that the ground wire insulation had begun to melt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2009-00001 |
| MDR Report Key | 2601770 |
| Report Source | 99 |
| Date Received | 2009-10-02 |
| Date of Report | 2009-08-05 |
| Date of Event | 2009-08-05 |
| Date Added to Maude | 2012-06-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GETINGE |
| Generic Name | WASHER DISINFECTOR |
| Product Code | MDZ |
| Date Received | 2009-10-02 |
| Model Number | 9125 |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | VAXJO 35115 SW 351 15 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-02 |