MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-05 for ZYMED HOLTER SOFTWARE 860292 manufactured by Philips Medical Systems.
[4453814]
The customer reported needing assistance changing a name on a report. Initially, the information provided in the fse notes and customer description led the investigator to a no malfunction, customer requesting assistance for a typo. After some investigation and communication with the field, product support and customer, the biu has decided to report the failure while the investigation is conducted for the potential for patient data mismatch. 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
[11872613]
Pr#: (b)(4). A follow up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-02368 |
| MDR Report Key | 3824365 |
| Report Source | 06 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-04-24 |
| Date Mfgr Received | 2014-04-24 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-06-23 |
| 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 | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYMED HOLTER SOFTWARE |
| Product Code | MLO |
| Date Received | 2014-05-05 |
| Model Number | 860292 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-05-05 |