FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2826435
·
Received October 18, 2012
Report
- Report Number
- 3003793491-2012-00087
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- April 5, 2012
- Report Date
- April 5, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REPORTED COMPLAINT OF "AUTOPULSE SHUTS DOWN IN A COUPLE OF MINUTES" WAS NOT DUPLICATED USING A TEST BATTERY. FURTHERMORE, NO BATTERIES WERE RECEIVED WITH THIS UNIT. EXPERIENCED EVENT HAD BEEN LOGGED IN THE ARCHIVE FILES, BUT IT WAS MOST LIKELY CAUSED BY THE BATTERY, WHICH WAS NOT RETURNED FOR EVALUATION. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AUTOPULSE SHUTS DOWN IN A COUPLE OF MINUTES RUNNING. FOUR DIFFERENT BATTERIES WERE USED. BATTERY MANAGEMENT IS IN PLACE. CUSTOMER WILL SEND IN A BATTERY FOR EVALUATION WITH THE AUTOPULSE. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC. | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |