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 2009-04-22 for HOLTER 2010 PLUS SOFTWARE M3741A manufactured by Philips Healthcare.
[16500516]
The customer reported that they scanned three different ecg files for three different patients, transmitted them to the remote site, and found them to be all the same. Philips worked with the customer to understand the problem and to do an investigation. The problem was caused by the customer accidentally transmitting training files instead of ecg files taken from the recorder. The customer was given instructions on how to avoid accidentally loading and transmitting training files. Though there was no reported injury or misdiagnosis, we are considering this to be a reportable event caused by a combination of user error and poor labeling of the ecg training files, the customer reported that they scanned three different ecg files for three different patients, transmitted them to the remote site, and found them to be all the same. Philips worked with the customer to understand the problem and to do an investigation. The problem was caused by the customer accidentally transmitting training files instead of ecg files taken from the recorder. The customer was given instructions on how to avoid accidentally loading the transmitting training files. Though there was no reported injury or misdiagnosis, we are considering this to be a reportable event caused by a combination of user error and poor labeling of the ecg training files. The customer did not provide a serial number associated with this event. There was no device failure.
Patient Sequence No: 1, Text Type: N, H10
[16643460]
The customer reported that they scanned three different ecg files for three different patients, transmitted them to the remote site, and found them to be all the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2009-00470 |
| MDR Report Key | 1368454 |
| Report Source | 05,06,07 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-03-23 |
| Date Mfgr Received | 2009-03-23 |
| Date Added to Maude | 2009-10-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATTI NILL |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| 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 | HOLTER 2010 PLUS SOFTWARE |
| Product Code | MLO |
| Date Received | 2009-04-22 |
| Model Number | M3741A |
| Catalog Number | M3741A |
| 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 HEALTHCARE |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-22 |