MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-20 for PROCTOSCOPE POWER TRANSFORMER 73305 manufactured by Welch Allyn Holdings Inc.
[16368561]
Transformer unit is coming apart at the plug housing, exposing the electrical wires and circuit board. This is the second transformer unit this has happened to. The first time it happened, about 3 months ago, we reported it directly to the company and received a new one in return. It appears that the plastic prongs designed to hold the housing together are breaking far too easily. This is a piece of durable medical equipment. But when they started breaking the first time, we had ordered some extra transformers just in case. We used the last one of those extras to keep the set operational this week, so the next time one breaks, the or will be down one proctoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004778 |
| MDR Report Key | 970328 |
| Date Received | 2007-12-20 |
| Date of Report | 2007-12-20 |
| Date of Event | 2007-11-08 |
| Date Added to Maude | 2008-01-04 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCTOSCOPE POWER TRANSFORMER |
| Generic Name | PROCTOSCOPE POWER TRANSFORMER |
| Product Code | GCF |
| Date Received | 2007-12-20 |
| Returned To Mfg | 2007-11-30 |
| Model Number | 73305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 941139 |
| Manufacturer | WELCH ALLYN HOLDINGS INC |
| Manufacturer Address | 4341 STATE ST RD SKANEATELES FALLS NY 131535300 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-20 |