LUCAS 3 CHEST COMPRESSION SYSTEM
Report
- Report Number
- 3005445717-2024-00004
- Event Type
- Death
- Date Received
- February 6, 2024
- Date of Event
- January 5, 2024
- Report Date
- July 17, 2024
- Manufacturer
- JOLIFE AB - 3005445717
- Product Code
- DRM
- PMA / PMN Number
- K173553
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.
FURTHER INVESTIGATION OF THE DEVICE FOUND THE HOOD CRACKED, THE BELT COVER DAMAGED, THE FAN WIRES PINCHED AND EXPOSED AND THE PCBA NOT PROPERLY SEATED TO THE PROTECTIVE BOARD. THESE ITEMS WERE REPLACED AND AFTER COMPLETING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
STRYKER EVALUATED THE CUSTOMER'S DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE CUSTOMER HAS BEEN ISSUED A QUOTE FOR REPAIRS NEEDED TO RESOLVE THE REPORTED ISSUE. A CLINICAL REVIEW WAS COMPLETED AND NO CONCLUSION CAN BE MADE REGARDING THE CONTRIBUTION OF THE EVENT ON THE PATIENT'S OUTCOME DUE TO INSUFFICIENT INFORMATION. CORRECTED DATA: THE INITIAL MEDWATCH REPORT INDICATED: G4: K161768. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: G4: K173553.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE AN ALARM AND WOULD NOT PROVIDE CARDIOPULMONARY RESUSCITATION DURING PATIENT USE. AS A RESULT, AN UNPLANNED PAUSE IN CARDIOPULMONARY RESUSCITATION WOULD HAVE OCCURRED, IF NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE AN ALARM AND WOULD NOT PROVIDE CARDIOPULMONARY RESUSCITATION DURING PATIENT USE. AS A RESULT, AN UNPLANNED PAUSE IN CARDIOPULMONARY RESUSCITATION WOULD HAVE OCCURRED, IF NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE GAVE AN ALARM AND WOULD NOT PROVIDE CARDIOPULMONARY RESUSCITATION DURING PATIENT USE. AS A RESULT, AN UNPLANNED PAUSE IN CARDIOPULMONARY RESUSCITATION WOULD HAVE OCCURRED, IF NEEDED. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1791424 | LUCAS 3 CHEST COMPRESSION SYSTEM | COMPRESSOR, CARDIAC, EXTERNAL | DRM | JOLIFE AB - 3005445717 | LUCAS 3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Female | Death |