LUCAS 3 CHEST COMPRESSION SYSTEM
Report
- Report Number
- 0003015876-2024-01513
- Event Type
- Injury
- Date Received
- May 7, 2024
- Date of Event
- March 1, 2024
- Report Date
- September 13, 2024
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- DRM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- 003
Narratives
STRYKER WILL NOT REQUEST ANY PATIENT IDENTIFYING INFORMATION TO BE IN ACCORDANCE WITH REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER INFORMED STRYKER THAT NO FURTHER PATIENT INFORMATION IS AVAILABLE. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. STRYKER PERFORMED A CLINICAL REVIEW REGARDING THE REPORTED ISSUE. NEVERTHELESS, IT CANNOT BE EXCLUDED THAT THE SPINE FRACTURE OCCURRED AFTER LUCAS CPR. THE AUTHOR ALSO CONFIRMS THAT LUCAS COMPRESSIONS WERE THE CAUSE OF THE SPINE FRACTURE. HOWEVER, IT IS LIKELY THAT THE FRACTURE DID NOT CONTRIBUTE TO THE PATIENT¿S OUTCOME.
THE CUSTOMER WAS CONTACTED ABOUT THE LUCAS MODEL THAT WAS USED IN THE REPORTED EVENT. THE CUSTOMER PROVIDED US AN ANSWER.
ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO STRYKER FOR FURTHER EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED OR DUPLICATED AND THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.
IT WAS REPORTED TO STRYKER THAT A 70 YEAR-OLD PATIENT PRESENTED SIGNS OF ANKYLOSING SPONDYLITIS AND AN UNSTABLE CHANCE FRACTURE OF THE 12TH THORACIC VERTEBRA. THE PATIENT ASSOCIATED WITH THE REPORTED DIED. THIS WAS FOUND DURING A LITERATURE REVIEW.
IT WAS REPORTED TO STRYKER THAT A 70 YEAR-OLD PATIENT PRESENTED SIGNS OF ANKYLOSING SPONDYLITIS AND AN UNSTABLE CHANCE FRACTURE OF THE 12TH THORACIC VERTEBRA. THE PATIENT ASSOCIATED WITH THE REPORTED DIED. THIS WAS FOUND DURING A LITERATURE REVIEW.
IT WAS REPORTED TO STRYKER THAT A 70 YEAR-OLD PATIENT PRESENTED SIGNS OF ANKYLOSING SPONDYLITIS AND AN UNSTABLE CHANCE FRACTURE OF THE 12TH THORACIC VERTEBRA. THE PATIENT ASSOCIATED WITH THE REPORTED DIED. THIS WAS FOUND DURING A LITERATURE REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380932 | LUCAS 3 CHEST COMPRESSION SYSTEM | COMPRESSOR, CARDIAC, EXTERNAL | DRM | PHYSIO-CONTROL, INC. - 3015876 | LUCAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Other |