MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-31 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[185797030]
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
[185797031]
Complainant alleged that during biomed testing, the device inappropriately shut down. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[188004687]
The device was returned to zoll medical corporation; the customer's report was observed during review of the device's history log. The device was put through extensive testing including bench handling, power cycling, full functionality, and stress testing. Without duplicating the report. The digital board was replaced as a precaution. The device passed the final test procedure, was recertified, and returned to the customer. Analysis for reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2020-00801 |
| MDR Report Key | 9903646 |
| Report Source | FOREIGN |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | R SERIES DEFIBRILLATOR |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | MKJ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-19 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| 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 | 2020-03-31 |