MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.
[138771920]
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation. Please refer to the user medwatch report that zoll medical has received.
Patient Sequence No: 1, Text Type: N, H10
[138771921]
Complainant alleged that while attempting to defibrillate a (b)(6) male patient, the device displayed a "defib pad short" message. Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient and received the same error. Complainant indicated that the patient subsequently expired. Please reference medwatch report 1220908-2019-00628 for the other defibrillator used in the event.
Patient Sequence No: 1, Text Type: D, B5
[140308352]
This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also correcting information submitted on the initial medwatch report. The customer was contacted for return of the suspect product. The product has not been returned to zoll for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145474621]
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included bench handling, multiple 30 joules self-tests, shock testing at various joules settings utilizing the returned multifunction cable and continuity testing without duplicating the reported malfunction. The device's biphasic cable was replaced as a precaution. The device was recertified and returned to the customer. No trend is associated with reports of this type. Please refer to the attached user medwatch report that zoll medical has received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-00648 |
| MDR Report Key | 8420089 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-15 |
| Date Facility Aware | 2019-02-15 |
| Report Date | 2019-02-20 |
| Date Reported to FDA | 2019-02-20 |
| Date Reported to Mfgr | 2019-02-19 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2019-03-14 |
| 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 | 2019-03-14 |
| Model Number | MSERIES BI-PHASIC |
| Catalog Number | M SERIES |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Death | 2019-03-14 |