MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-24 for TRANSCUTANEOUS MONITOR TCM3 manufactured by Radiometer Copenhagen.
[22174556]
The groundong pin on the transcutaneous monitor power transformer had broken loose from the mounting base of the transformer and came in contact with the a. C. Power pins. This caused the pts' head wall circuit breaker to lose all electrical power. There was no change in status of the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35001 |
| MDR Report Key | 35001 |
| Date Received | 1996-07-24 |
| Date of Event | 1996-05-17 |
| Date Added to Maude | 1996-08-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TRANSCUTANEOUS MONITOR TCM3 |
| Generic Name | TRANSCUTANEOUS MONITOR TCM3 |
| Product Code | CCC |
| Date Received | 1996-07-24 |
| Returned To Mfg | 1996-06-05 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 36416 |
| Manufacturer | RADIOMETER COPENHAGEN |
| Manufacturer Address | 811 SHARON DR WESTAKE OH 44145 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-24 |