MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-10-02 for ZYMED HOLTER SOFTWARE 860292 manufactured by Philips Medical Systems.
[1169063]
The customer reported that a study was overwritten by another study, which resulted in the pt receiving unnecessary treatment. There was no adverse event, and no harm was done to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8370744]
The customer reported that a study was overwritten by another study, which resulted in the pt receiving unnecessary treatment. There was no adverse event, and no harm was done to the pt. A philips clinical specialist evaluated the system at the customer site and determined that the study had been overwritten by another file that the customer had created. We consider this to be a malfunction, caused by the user overwriting a file. Philips has made the customer aware of the cause of the overwritten file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-01439 |
| MDR Report Key | 1490835 |
| Report Source | 05,06,07 |
| Date Received | 2009-10-02 |
| Date of Report | 2009-09-02 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2009-10-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATTI NILL |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786593769 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYMED HOLTER SOFTWARE |
| Product Code | MLO |
| Date Received | 2009-10-02 |
| Model Number | 860292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-02 |