MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[185794356]
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[185794357]
Complainant alleged that during biomed testing, the device failed self test. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[188004827]
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
| Report Number | 1220908-2020-00809 |
| MDR Report Key | 9904348 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2009-08-01 |
| 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 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| Device Availability | N |
| 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 |