MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-30 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[4609611]
Complainant alleged that during training by facility staff, the device displayed "defib fault 76" and "defib disabled" messages. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[11944032]
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2014-01297 |
| MDR Report Key | 3966507 |
| Report Source | 99 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-13 |
| Date Mfgr Received | 2014-05-13 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2014-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT AUGUST |
| 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 | LIX |
| Date Received | 2014-05-30 |
| Returned To Mfg | 2014-05-20 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | CHELMSFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |