MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-25 for IPRESARIO SOLO * manufactured by Del Mar Reynolds Medical, Inc..
[503198]
The holter analysis system prints strips of holter ecg. Waveforms are displayed correctly; but on the analysis report from which a diagnosis is being made the waveforms are compressed to the point of eliminating the p-wave of the waveform. The p-wave is vital for diagnosing av block. Del mar has attempted to correct the problem stating that the compression of the wave forms was caused by the monitor resolution. A new computer monitor was installed. This did not help the problem. They say they are consulting their engineering section to try to find a software solution. This has been an ongoing issue with their software since its purchase in march of 2006. Follow up reveals: the manufacturer has given the facility a solution deadline of september 31st.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 759886 |
| MDR Report Key | 759886 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-08-25 |
| Date of Event | 2006-03-23 |
| Report Date | 2006-08-25 |
| Date Reported to FDA | 2006-08-25 |
| Date Added to Maude | 2006-09-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPRESARIO SOLO |
| Generic Name | HOLTER SYSTEM, ECG |
| Product Code | MWJ |
| Date Received | 2006-08-25 |
| Model Number | IPRESARIO SOLO |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 747805 |
| Manufacturer | DEL MAR REYNOLDS MEDICAL, INC. |
| Manufacturer Address | 13 WHATNEY STREET IRVINE CA 92618 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-25 |