FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2873573
·
Received November 14, 2012
Report
- Report Number
- 3003793491-2012-00228
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 15, 2012
- Manufacturer
- ZOLL CIRCULATION, INC.
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO THE MFR DID NOT INDICATE A POTENTIAL SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE MFR AND ANALYZED. VISUAL INSPECTION DISCLOSED THAT THE FRONT ENCLOSURE AND BATTERY LOCK WERE DAMAGED. ARCHIVE DATA EXHIBITED MULTIPLE UA 08 MESSAGES AND CONFIRMED THE CUSTOMER'S INITIAL COMPLAINT. IT WAS ALSO OBSERVED THAT THE FIRMWARE NEEDED TO BE UPGRADED AND THE MOTOR CONTROLLER BOARD WAS BAD. THE MOTOR CONTROLLER BOARD, FRONT ENCLOSURE AND BATTERY LOCK WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN AUTOPULSE RESUSCITATION SYSTEM WITH S/N (B)(4) DISPLAYED A USER ADVISORY MESSAGE OF 08 (MOTOR CONTROLLER FAULT DETECTED) THAT WAS UNABLE TO BE CLEARED UPON PT USAGE. THERE WAS NO REPORT OF A PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST CIMPRESSOR | DRM | ZOLL CIRCULATION, INC. | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |