MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for DIGITRAK XT HOLTER RECORDER 860322 manufactured by Philips Medical Systems.
[87629981]
A follow up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[87629982]
The customer reported having data integrity issues with philips holter monitors via lifewatch services. A patient's cardiology information was merged with another patient, such that the patient was believed to have atrial fibrillation when he did not. The customer is concerned about a data integrity issue and was unable to receive help with a resolution via lifewatch services. 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. The patient was given medication that was not needed, but there was no harm to the involved patient.
Patient Sequence No: 1, Text Type: D, B5
[105720522]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-06580 |
| MDR Report Key | 6889496 |
| 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 | DIGITRAK XT HOLTER RECORDER |
| Generic Name | DIGITRAX XT HOLTER RECORDER |
| Product Code | MWJ |
| Date Received | 2017-09-25 |
| Model Number | 860322 |
| 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 |