MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME 5TH WHEEL STRETCHER 26"; STRETCHER, WHEELED

Catalog Number	1105000026
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanical Jam (2983)
Health Effect - Clinical Codes	Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has stiffness/steering issues.A staff member completed an incident report complaining of back pain, which caused them to take sick leave days.Attempts are being made to gather additional details from the user facility.
Additional Manufacturer Narrative
It was reported by the customer that there was an injury to a staff member as a result of the stretcher being stiff and difficult to steer.It was further reported that the injury the staff member sustained was back pain, which caused them to take time off work.The serial number of the unit in which this event occurred was not documented by the customer at the time of the event.Therefore, two units were evaluated as a sample from the stretchers at the account.A visual and functional inspection was performed by a stryker field service technician.It was identified that there was no component-level defect or malfunction which could have caused or contributed to the start-up resistance/rolling resistance being too great.This issue was resolved for the customer by confirming that there was no component-level defect or malfunction with the sample units evaluated.
Event or Problem Description
It was reported that the device has stiffness/steering issues.A staff member completed an incident report complaining of back pain, which caused them to take sick leave days.

• Brand Name: PRIME 5TH WHEEL STRETCHER 26"
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18310975
• Report Number: 0001831750-2023-01362
• Device Sequence Number: 6151927
• Product Code: FPO
• UDI-Device Identifier: 07613327278149
• UDI-Public: 07613327278149
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1105000026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown