MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-04 for DIAGNOSTIC MONITORING DL-700 * manufactured by Diagnostic Monitoring/advanced Biosensor.
[15486646]
A holter monitor using a digital flash card for memory was placed on a pt with one battery reversed in the recorder. The monitor failed to record and failed to erase the previous pt's ekg data. When the monitor was returned it was scanned, it appeared to have worked and was a very abnormal recording. The technologist noticed that the recording had the same abnormalities as a holter scanned on a different pt a week earlier. It was then determined that the data did belong to another pt. If this error had been undetected the pt could have been treated for an arrhythmia they did not have; the pt could even have been sent to surgery to have pacemaker implanted. The battery being reversed was the original mistake - but if the holter system made it automatic or easy to erase the memory card after scanning, this potential error would be much less likely to occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026374 |
| MDR Report Key | 421324 |
| Date Received | 2002-10-09 |
| Date of Report | 2002-10-04 |
| Date of Event | 2002-09-18 |
| Date Added to Maude | 2002-10-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DIAGNOSTIC MONITORING |
| Generic Name | HOLTER MONITOR - WITH DIGITAL FLASH CARD |
| Product Code | MWJ |
| Date Received | 2002-10-04 |
| Model Number | DL-700 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 410355 |
| Manufacturer | DIAGNOSTIC MONITORING/ADVANCED BIOSENSOR |
| Manufacturer Address | 11481 RUPP DR BURNSVILLE MN 55337 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-10-09 |