FDA Adverse Event
Malfunction
Summary report: N
AUTOCLAVABLE HANDLES, OVERMOLDED
MDR report key: 3932128
·
Received April 3, 2014
Report
- Report Number
- 1220908-2014-00810
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 17, 2014
- Report Date
- March 17, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- LDD
- PMA / PMN Number
- K032691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE WITH THESE INTERNAL HANDLES ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200259 | AUTOCLAVABLE HANDLES, OVERMOLDED | AUTOCLAVABLE HANDLES | LDD | ZOLL MEDICAL CORPORATION | 1011-0140 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |