MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-03 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[16780430]
Complainant alleged that while attempting to pace a male patient (age unk), the device failed to capture the patient's heart rhythm. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[16968911]
Zoll medical corporation has not yet received the devic for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1220908-2014-00811 |
MDR Report Key | 3932146 |
Report Source | 05 |
Date Received | 2014-04-03 |
Date of Report | 2014-03-17 |
Date of Event | 2014-03-11 |
Date Mfgr Received | 2014-03-17 |
Device Manufacturer Date | 2013-06-01 |
Date Added to Maude | 2014-07-24 |
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 | R SERIES DEFIBRILLATOR |
Product Code | LIX |
Date Received | 2014-04-03 |
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 | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ZOLL MEDICAL CORPORATION |
Manufacturer Address | CHELMSFORD MA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-04-03 |