FDA Adverse Event
Malfunction
Summary report: N
MULTI FUNCTION CABLE (1600)
MDR report key: 218466
·
Received April 8, 1999
Report
- Report Number
- 1220908-1999-00249
- Event Type
- Malfunction
- Date Received
- April 8, 1999
- Date of Event
- February 16, 1999
- Report Date
- March 10, 1999
- Manufacturer
- ZOLL MEDICAL CORPORATION.
- Product Code
- DSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT THE CLINICIANS WERE ATTEMPTING TO DEFIBRILLATE A 92 YEAR OLD MALE PT USING A 1600 MODEL DEVICE WITH THE MULTI-FUNCTION CABLE, BUT THE DEVICE WOULD NOT CHARGE. IN ADDITION, THE DEVICE SCREEN DISPLYED A DOTTED LINE AND A "CHECK ELECTRODES" ERROR MESSAGE. THE COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI FUNCTION CABLE (1600) | MFC CABLE | DSA | ZOLL MEDICAL CORPORATION. | 80001601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other |