MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for ZOLL PD-1200 PD 1200 manufactured by Zmi Corporation.
[10428]
Patient brought in by ambulance in full cardiopulmonary arrest with cpr in progress. Quick-look paddles applied and patient defibrillated at 200 joules. After initial defibrillation, they could not obtain the patient's rhythm with the paddles. Time had to be taken to attach leads before they could give their second defibrillation. We follow acls protocols which calls for 3 rapid defibrillations in succession.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16026 |
| MDR Report Key | 16026 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-04-11 |
| Date of Event | 1994-04-10 |
| Date Facility Aware | 1994-04-10 |
| Report Date | 1994-04-11 |
| Date Reported to Mfgr | 1994-04-11 |
| Date Added to Maude | 1994-09-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL PD-1200 |
| Generic Name | MONITOR/DEFIBRILLATOR/PACEMAKER |
| Product Code | DRK |
| Date Received | 1994-07-21 |
| Returned To Mfg | 1994-04-11 |
| Model Number | PD 1200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4.5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15959 |
| Manufacturer | ZMI CORPORATION |
| Manufacturer Address | 500 WEST CUMMINGS PARK WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-21 |