AUTOPULSE RESUSCITATION SYSTEM MODEL 100
Report
- Report Number
- 3003793491-2013-00599
- Event Type
- Death
- Date Received
- May 23, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 30, 2013
- Manufacturer
- ZOLL CIRCULATION, INC
- Product Code
- DRM
- PMA / PMN Number
- K112998
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE BATTERY LOCK WAS DAMAGED. FUNCTIONAL TESTING WAS PERFORMED WITH NO PROBLEMS. CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED DURING INVESTIGATION. ARCHIVE DATA REVIEW INDICATED THAT LOW BATTERY MESSAGES WERE PRESENT ON THE REPORTED DATE OF COMPLAINT. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. PLEASE SEE RELATED MFR REPORT #3003793491-2013-00600 FOR COMPLAINT AGAINST BATTERY SN (B)(4) AND 3003793491-2013-00601 FOR COMPLAINT AGAINST BATTERY WITH SN (B)(4).
IT WAS REPORTED THAT THE AUTOPULSE PLATFORM FAILED ON A FULL-ARREST PT. THE PLATFORM GAVE 15 COMPRESSIONS ON ONE BATTERY (SN (B)(4) AND 2 COMPRESSIONS ON A SECOND BATTERY (SN (B)(4)). THE UNIT HAS BEEN TAKEN OUT OF SERVICE UNTIL FURTHER NOTICE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013: MANUAL CPR WAS INITIATED. PT WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS NOT PROVIDED. THIS REPORT WILL COVER THE COMPLAINT AGAINST THE AUTOPULSE PLATFORM (SN (B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228207 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION, INC | MODEL 100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Death | MANUAL CPR |