MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for ZOLL PADDLES R SERIES manufactured by Zoll Medical Corporation.
[146066135]
During the pt's heart cath, the pt went into v-fib; attempted to shock the pt with zoll paddles at 200 j x 2 attempts (with monitor buttons and then the paddle buttons) with no success. Cpr continued and another defibrillator had to be used to shock the pt. The pt was successfully shocked and returned to nsr. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086841 |
| MDR Report Key | 8636161 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-14 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZOLL PADDLES |
| Generic Name | ZOLL PADDLES DC - DEFIBRILLATOR, LOW ENERGY |
| Product Code | LDD |
| Date Received | 2019-05-22 |
| Returned To Mfg | 2019-05-14 |
| Model Number | R SERIES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-22 |