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 manufactured by Zmi Corporation.
[18552184]
Patient in midst of evolving acute myocardial infarction and subsequently went into atrial fib with slow ventricular response in 30's to 50's. Pt. Symptomatic with systolic bp dropping to 60-80's, decreased mentation and diapharesis. Pt. Was placed on dopamine drip and prepared for transfer to another tertiary facility. Pd-1200 was gotten from er (had been plugged in) and taken to scu on 2nd floor. Pacer patches and monitoring leads applied to patient. Pacer left on standby only. Pt. Loaded on ambulance stretcher and started down elevator when monitor went blank. We got to ambulance and plugged unit in. It functioned for approximately 1 minute and it again went blank, i turned it off and turned it back on again. It worked for approximately 2-3 minutes when it again went blank. We had to attach pt. To ambulance monitor/defibrillator to monitor pt. We no longer had pacer ability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15989 |
| MDR Report Key | 15989 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-04-11 |
| Date of Event | 1994-04-07 |
| Date Facility Aware | 1994-04-07 |
| Report Date | 1994-04-11 |
| Date Reported to Mfgr | 1994-04-11 |
| Date Added to Maude | 1994-09-09 |
| 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 | Y |
| Device Age | 4.5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15922 |
| Manufacturer | ZMI CORPORATION |
| Manufacturer Address | 500 WEST CUMMINGS PARK WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Other | 1994-07-21 |