MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for INNERVATOR NS-252 NA manufactured by Fisher & Paykel Healthcare.
[5714]
Both proximal and distal jack receptacles come loose when removing the leadwires. This exposes the internal wires, making it a potential shock hazard for the user. This type receptacle normally has a "d" style mount to prevent such twisting. However, it is not present in this device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003069 |
| MDR Report Key | 15185 |
| Date Received | 1994-08-11 |
| Date of Report | 1994-08-01 |
| Date of Event | 1994-06-23 |
| Date Added to Maude | 1994-08-12 |
| 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 | INNERVATOR |
| Product Code | KOI |
| Date Received | 1994-08-11 |
| Model Number | NS-252 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15178 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE |
| Manufacturer Address | WALLKILL NY 12589 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-11 |