MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-15 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.
[138946102]
The device was returned to zoll medical corporation for evaluation. During the investigation, the technician discovered that the customer attempted repair of the device. As a result of the device being tampered with, component root cause could not be firmly established for this report. A system interconnection flex cable was replaced as a precaution. The device was recertified and returned to the customer. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
[138946103]
Complainant alleged that during a routine shift check by a clinician, the device displayed a "defib pad short" message. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2019-00624 |
| MDR Report Key | 8425201 |
| Date Received | 2019-03-15 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2019-03-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M SERIES |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | DPS |
| Date Received | 2019-03-15 |
| Returned To Mfg | 2019-02-28 |
| Model Number | MSERIES BI-PHASIC |
| Catalog Number | M SERIES |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-15 |