MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-06-24 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[4586264]
Complainant alleged that while attempting to treat a patient, the device's main knob fell off and they were unable to power up the device. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[12033804]
The device was not returned to zoll medical corporation, instead this issue was resolved onsite by the customer. The customer added glue to reattach the knob to the main shaft. The device then functioned clinically. The device will not be returning to zoll. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2014-01535 |
| MDR Report Key | 3924928 |
| Report Source | 01 |
| Date Received | 2014-06-24 |
| Date of Report | 2014-06-04 |
| Date Mfgr Received | 2014-06-04 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2014-07-22 |
| 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 | 2014-06-24 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-06-24 |