PRIME ELECTRIC BIG WHEEL STRETCHER
Report
- Report Number
- 0001831750-2024-00324
- Event Type
- Death
- Date Received
- March 4, 2024
- Date of Event
- February 22, 2024
- Report Date
- April 3, 2025
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- UDI-DI
- 07613327278217
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS REPORTED BY THE CUSTOMER THAT ALLEGEDLY A DEATH OF A PATIENT HAD OCCURRED AS THEY MANAGED TO GET THEIR HEAD STUCK BETWEEN THE BARRIERS OF THE PRIME X STRETCHER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. PATIENT FOUND AT 8:05 PM WITH HER HEAD STUCK IN THE BARS OF THE STRETCHER. THE PATIENT WAS IN CARDIORESPIRATORY ARREST. SHE HAD PREVIOUSLY BEEN REINSTALLED BY THE HEALTHCARE TEAM AT 7:55 P.M. FOLLOWING HER RETURN FROM A RADIOLOGY EXAMINATION. ADDITIONAL DATA COLLECTED DURING DOCUMENTATION OF THE ADVERSE EVENT: ONE ARM AND THE PATIENT'S HEAD WERE TRAPPED IN THE SPACE BETWEEN THE BARRIER BARS, THE PATIENT WAS INSTALLED IN THE DESHOCK ROOM, NOT MONITORED, INCIDENT OCCURRED BETWEEN 7:55 PM AND 8:05 PM WITHOUT WITNESSES. THE UNIT INVOLVED IN THIS EVENT WAS NOT MADE AVAILABLE FOR FURTHER EVALUATION BY STRYKER MEDICAL PERSONNEL. BASED ON THE AVAILABLE INFORMATION PROVIDED BY THE ACCOUNT, EVENT DESCRIPTION, AND PREVIOUS SIMILAR COMPLAINTS, A STRYKER SR. QAE DETERMINED THAT THE ENTRAPMENT WITHIN THE SIDERAIL, WHICH RESULTED IN A PATIENT DEATH, WAS LIKELY NOT DUE TO ANY COMPONENT LEVEL DEFECT OF THE PRODUCT. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT MADE AVAILABLE FOR PHYSICAL EVALUATION BY STRYKER PROCARE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY DOCUMENTING THE COMPLAINT AND INFORMING THEM TO REQUEST EVALUATION VIA STRYKER PROCARE IF ANY FUTURE CONCERNS EXIST.
THE ADDITIONAL MANUFACTURING SUMMARY BELOW HAS BEEN UPDATED TO REMOVE THE INCORRECT REFERENCE TO THE DEVICE USED BY THE CUSTOMER: IT WAS REPORTED BY THE CUSTOMER THAT ALLEGEDLY A DEATH OF A PATIENT HAD OCCURRED AS THEY MANAGED TO GET THEIR HEAD STUCK BETWEEN THE BARRIERS OF THE STRETCHER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. PATIENT FOUND AT 8:05 PM WITH HER HEAD STUCK IN THE BARS OF THE STRETCHER. THE PATIENT WAS IN CARDIORESPIRATORY ARREST. SHE HAD PREVIOUSLY BEEN REINSTALLED BY THE HEALTHCARE TEAM AT 7:55 P.M. FOLLOWING HER RETURN FROM A RADIOLOGY EXAMINATION. ADDITIONAL DATA COLLECTED DURING DOCUMENTATION OF THE ADVERSE EVENT: ONE ARM AND THE PATIENT'S HEAD WERE TRAPPED IN THE SPACE BETWEEN THE BARRIER BARS, THE PATIENT WAS INSTALLED IN THE DESHOCK ROOM, NOT MONITORED, INCIDENT OCCURRED BETWEEN 7:55 PM AND 8:05 PM WITHOUT WITNESSES. THE UNIT INVOLVED IN THIS EVENT WAS NOT MADE AVAILABLE FOR FURTHER EVALUATION BY STRYKER MEDICAL PERSONNEL. BASED ON THE AVAILABLE INFORMATION PROVIDED BY THE ACCOUNT, EVENT DESCRIPTION, AND PREVIOUS SIMILAR COMPLAINTS, A STRYKER SR. QAE DETERMINED THAT THE ENTRAPMENT WITHIN THE SIDERAIL, WHICH RESULTED IN A PATIENT DEATH, WAS LIKELY NOT DUE TO ANY COMPONENT LEVEL DEFECT OF THE PRODUCT. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT MADE AVAILABLE FOR PHYSICAL EVALUATION BY STRYKER PROCARE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY DOCUMENTING THE COMPLAINT AND INFORMING THEM TO REQUEST EVALUATION VIA STRYKER PROCARE IF ANY FUTURE CONCERNS EXIST.
IT WAS REPORTED THAT A PATIENT'S HEAD WAS STUCK- IN BETWEEN THE BARRIERS OF THE DEVICE, AND THE PATIENT DIED.
IT WAS REPORTED THAT A PATIENT'S HEAD WAS STUCK- IN BETWEEN THE BARRIERS OF THE DEVICE, AND THE PATIENT DIED. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.
IT WAS REPORTED THAT A PATIENT'S HEAD WAS STUCK- IN BETWEEN THE BARRIERS OF THE DEVICE, AND THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144715 | PRIME ELECTRIC BIG WHEEL STRETCHER | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 07613327278217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |