MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for NIHON KOHDEN TELEMETRY PACK BATTERY ZM 930PA manufactured by Nihon Kohden America Inc..
[111193627]
On (b)(6) 2018 at 23:00, the telemetry pack became hot, when the nurse removed to investigate, one of the batteries (procell aa 1. 5v lr6 pc1500) had began to peel. The telemetry pack was removed and taken out of service. Dates of use: (b)(6) 2018, diagnosis or reason for use: elevated troponin. "is the product compounded: no, is the product over-the-counter: no. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077817 |
| MDR Report Key | 7596256 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-06-07 |
| Date Added to Maude | 2018-06-13 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NIHON KOHDEN TELEMETRY PACK BATTERY |
| Generic Name | TRANSMITTER |
| Product Code | GWL |
| Date Received | 2018-06-12 |
| Model Number | ZM 930PA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN AMERICA INC. |
| Brand Name | NIHON KOHDEN TELEMETRY PACK BATTERY |
| Generic Name | TRANSMITTER |
| Product Code | GWL |
| Date Received | 2018-06-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN AMERICA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-12 |