AUTOPULSE® LIFEBAND
Report
- Report Number
- 3010617000-2024-00309
- Event Type
- Malfunction
- Date Received
- April 13, 2024
- Report Date
- April 13, 2024
- Manufacturer
- ZOLL CIRCULATION
- Product Code
- DRM
- UDI-DI
- 00849111001571
- PMA / PMN Number
- K112998
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
THE REPORTED COMPLAINT OF DAMAGED AUTOPULSE LIFEBAND (LOT #182214) WAS CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RETURNED LIFEBAND AND PROVIDED PICTURES. THE LIFEBAND SHOWS DAMAGE INDICATIVE OF A TWISTED BELT DURING USE. THE HINGED BELT GUARD OF THE LIFEBAND WAS DAMAGED, LIKELY DUE TO THE EXCESSIVE FORCE APPLIED WHEN THE TWISTED BELT WAS MOVING THROUGH THE HINGED BELT GUARD OPENING, LIKELY ATTRIBUTED TO USER ERROR. THE FUNCTIONAL TESTING FOR THE LIFEBAND COULD NOT BE PERFORMED DUE TO THE OBSERVED DAMAGES. THE AUTOPULSE USER GUIDE PROVIDES THE FOLLOWING CAUTION - MAKE SURE THAT THE LIFEBAND IS NOT TWISTED BEFORE AUTOMATIC COMPRESSIONS BEGIN. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR LIFEBAND WITH LOT 182214. B3, THE DATE OF EVENT IS UNKNOWN.
PER THE REPORTER, THE AUTOPULSE LIFEBAND (LOT # 182214) WAS DAMAGED. THE ISSUE WAS OBSERVED AFTER THE USE OF THE AUTOPULSE PLATFORM (SN (B)(6)) DURING THE PATIENT CALL. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. B3, THE DATE OF EVENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779143 | AUTOPULSE® LIFEBAND | CARDIAC RESUSCITATOR BAND | DRM | ZOLL CIRCULATION | MODEL 100 | 182214 | 00849111001571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |