MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for LIFEWATCH HOLTER MONITOR manufactured by Lifewatch Services Inc..
[72203822]
Patient Sequence No: 1, Text Type: N, H10
[72203823]
Holter monitor done by lifewatch and when our physician reviewed the strips, it was clearly not the correct patient. The report from lifewatch did not have any atrial fibrillation noted when the primary reason for the holter was a-fib. Thankfully our physician noticed the error and did not offer any treatment based on the wrong report. Lifewatch was notified and they then sent a "corrected" report that had the a-fib noted. Based on this event, and the lack of support from lifewatch we have ceased all activity with this vendor. Manufacturer response for holter monitor, lifewatch holter monitor (per site reporter): the manufacturer/vendor has refused to discuss these ongoing data issues with us, they are requiring us to talk to their legal counsel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6474998 |
| MDR Report Key | 6474998 |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-03-20 |
| Report Date | 2017-04-07 |
| Date Reported to FDA | 2017-04-07 |
| Date Reported to Mfgr | 2017-04-07 |
| Date Added to Maude | 2017-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEWATCH HOLTER MONITOR |
| Generic Name | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH |
| Product Code | DXH |
| Date Received | 2017-04-10 |
| Returned To Mfg | 2017-03-13 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES INC. |
| Manufacturer Address | 10255 WEST HIGGINS RD. SUITE 110 ROSEMONT IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-10 |