MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-29 for MASTERSTIM I-2 manufactured by Health Care Manufacturing, Inc..
[10022]
A physician reported that a pt received a burn from this device. The device was sent to the rptr for repairs. On first inspection, nothing was found and the device was returned to the physician. The physician again sent the device back stating that it was still jumping in current. Simulating exactly how the physician used the device, the rptr found that an impedance shift in one channel caused current fluctuation in the second. A mfr's technician was also able to duplicate the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003531 |
| MDR Report Key | 16480 |
| Date Received | 1994-09-29 |
| Date of Report | 1994-09-27 |
| Date Added to Maude | 1994-09-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASTERSTIM I-2 |
| Generic Name | STIMULATOR |
| Product Code | LIH |
| Date Received | 1994-09-29 |
| Model Number | I-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16413 |
| Manufacturer | HEALTH CARE MANUFACTURING, INC. |
| Manufacturer Address | SPRINGFIELD MO 65802 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-29 |