MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-14 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[4608942]
Complainant alleged that during a routine shift check by a clinician, the device displayed "defib disabled" and "defib fault 76" messages. Complainant indicated that there was no pt involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[11978038]
Zoll medical corporation has received the product and will be providing a f/u report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2014-01197 |
| MDR Report Key | 3958601 |
| Report Source | 99 |
| Date Received | 2014-05-14 |
| Date of Report | 2014-04-29 |
| Date Mfgr Received | 2014-04-29 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2014-08-01 |
| 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 | 2014-05-14 |
| Returned To Mfg | 2014-05-02 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-05-14 |