MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for M SERIES MSERIES CCT manufactured by Zoll Medical Corporation.
[141524751]
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[141524752]
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed a "defib pad short" message. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that the patient subsequently expired.
Patient Sequence No: 1, Text Type: D, B5
[141907267]
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed. The device with multi-function cable were put through extensive testing including bench testing, impedance testing, defib cycle tests and various defib energies without duplicating the report. The device passed internal visual inspections. The device was recertified and returned to the customer. The electrodes involved were returned and visual inspection did not find any evidence that would inhibit the pads from shocking or causing a defib pad short condition. The electrodes were subjected to multiple discharge tests and the results were within specification. No data card was used during the event and no clinical logs were available as part of this investigation. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-00928 |
| MDR Report Key | 8501570 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-23 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2019-04-10 |
| 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 | 2019-04-10 |
| Returned To Mfg | 2019-04-02 |
| Model Number | MSERIES CCT |
| Catalog Number | M SERIES |
| Lot Number | NA |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-10 |