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

Catalog Number	1105000026
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the siderail joint broke and gave away.It was further reported that a patient fell out of the stretcher onto their head.Attempts are being made to gather potential injury and treatment details from the user facility.
Additional Manufacturer Narrative
The device was not evaluated and the serial number could not be obtained.
Event or Problem Description
It was reported that the siderail joint broke and gave away.It was further reported that a patient fell out of the stretcher onto their head.It was further reported that the patient was not harmed.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18762904
• Report Number: 0001831750-2024-00316
• Device Sequence Number: 7739782
• Product Code: FPO
• UDI-Device Identifier: 07613327278149
• UDI-Public: 07613327278149
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1105000026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Male