MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-28 for AC POWER PLUG TALLER BRIDGE PLUG manufactured by Electri-cord Mfg. Co. Mn Office.
[1333418]
(b) (4). Fda safety investigation of certain medical device power cords manufactured by electri-cord. So far the following companies have notified users that they may have the recalled electri-cord power cord on their equipment: additional companies have been added to the affected power cord list. I have followed the attached flow chart and have determined that the power cord/plug is affected by the fda recall and is exhibiting one of the characteristics as follows: if the plug has bent or cracked prongs, an outer sheath that is visibly burnt, a black residue, signs of excessive wear and tear. I have taken the following actions: contact of the medical device manufacturer or sales representative to report the power cord failure and to request the appropriate replacement/repair. I have removed the power plug/cord assembly, replaced with a verified correct component, safety tested, and returned equipment back into service. The (b) (4) supervisor has been notified of this work order for the need to report to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015066 |
| MDR Report Key | 1628984 |
| Date Received | 2009-12-28 |
| Date of Report | 2009-12-28 |
| Date Added to Maude | 2010-03-17 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AC POWER PLUG |
| Generic Name | AC POWER PLUG |
| Product Code | LDQ |
| Date Received | 2009-12-28 |
| Model Number | TALLER BRIDGE PLUG |
| Lot Number | TALLER BRIDGE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELECTRI-CORD MFG. CO. MN OFFICE |
| Manufacturer Address | 1190 EAGAN INDUSTRIAL ROAD EAGAN MN 55121 US 55121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-12-28 |