FDA Adverse Event
Malfunction
Summary report: N
PD1200 DEFIBRILLATOR/PACEMAKER
MDR report key: 2982513
·
Received November 24, 2004
Report
- Report Number
- 1220908-2004-02427
- Event Type
- Malfunction
- Date Received
- November 24, 2004
- Date of Event
- October 13, 2004
- Report Date
- October 29, 2004
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFERENCE THE USER MEDWATCH REPORT SUBMITTED TO ZOLL MEDICAL BY THE CUSTOMER. ADDITIONAL INFO FROM USER FACILITY REPORT: (B)(4).
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A (B)(6) FEMALE PT THE DEVICE DISCHARGED THREE DELIVERIES OF ENERGY TO THE PT. THE DEFIB ELECTRODE PADS WERE REMOVED AND A BURN MARK WAS NOTED ON THE PT BELOW THE ANTERIOR ELECTRODE. ADDITIONAL INFO FROM USER FACILITY REPORT: PT WENT INTO V-FIB IN CARDIAC CATH LAB. DEFIBBED X3 SUCCESSFUL. AFTER DEFIB BURN NOTED TO PTS LEFT CHEST BELOW ANTERIOR PAD. BURN MARK ON CHEST MATCHES BURN ON DEFIB PAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PD1200 DEFIBRILLATOR/PACEMAKER | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | PD1200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |