MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for ZYMED HOLTER SOFTWARE 860292 manufactured by Philips Medical Systems.
[87458963]
A follow-up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[87458964]
The customer reported that a philips holter monitor was being used via lifewatch services and when the physician reviewed the ecg strips, it was not the correct patient. The report provided via lifewatch services did not have any atrial fibrillation noted when the primary reason for the holter for this patient was atrial fibrillation. The physician noted the error and did not offer any treatment to the patient based on the incorrect report. Lifewatch services was notified by the customer and sent a corrected report that had the atrial fibrillation noted. Note that as of the time of this report, the correct philips holter product number is not known. Additional information has been requested of the customer. There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.
Patient Sequence No: 1, Text Type: D, B5
[105724892]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-06579 |
| MDR Report Key | 6889497 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZYMED HOLTER SOFTWARE |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM |
| Product Code | MLO |
| Date Received | 2017-09-25 |
| Model Number | 860292 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-25 |