MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-18 for * M-4 manufactured by Chattanooga Group.
[903562]
Brand new unit was undergoing initial acceptance testing in the biomedical department. The unit was visually inspected and showed no signs of damage and was in new condition. The unit was filled with water and connected to an electrical safety analyzer for the initial electrical safety test. Upon powering up the unit, the electrical safety analyzer began smoking and the 20 amp electrical breaker tripped in the electrical distribution panel. The manufacturer was notified and a replacement hydrocollator was sent. It is obvious that the unit is miswired and was a serious safety hazard. The electrical safety analyzer was destroyed. ====================== manufacturer response for hot pack machine, m4 hydrocollator======================tech support notified and a replacement unit was sent. No response from regulatory affairs on whether or not our safety analyzer will be repaired/replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1082891 |
| MDR Report Key | 1082891 |
| Date Received | 2008-07-18 |
| Date of Report | 2008-07-18 |
| Date of Event | 2008-07-10 |
| Report Date | 2008-07-18 |
| Date Reported to FDA | 2008-07-18 |
| Date Added to Maude | 2008-07-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HYDROCOLLATOR |
| Product Code | IRQ |
| Date Received | 2008-07-18 |
| Returned To Mfg | 2008-07-18 |
| Model Number | M-4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1048610 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS STREET HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-18 |