MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-25 for ZYMED DIGITRAK-PLUS 24 DIGITRAK PLUS 24 * manufactured by Zymed - Phillips.
[15481665]
Pt wears 24 hour holter monitor for 24 hour period. If pt comes back earlier than 24 hour countdown, then an early shutdown is done. This early shutdown of monitor somehow corrupts the digital data in monitor making it unable to extract data to review system computer. Pt is needed to wear system monitor again for another 24 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031670 |
| MDR Report Key | 520335 |
| Date Received | 2004-03-25 |
| Date of Report | 2004-03-17 |
| Date of Event | 2004-03-17 |
| Date Added to Maude | 2004-04-14 |
| 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 | UNKNOWN |
| 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 | ZYMED DIGITRAK-PLUS 24 |
| Generic Name | DIGITAL HOLTER RECORDING MONITOR |
| Product Code | MLO |
| Date Received | 2004-03-25 |
| Model Number | DIGITRAK PLUS 24 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 509431 |
| Manufacturer | ZYMED - PHILLIPS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-25 |