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

Catalog Number	1105000026
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the devices experienced reduced/inadequate brake force.There was no patient involvement.
Additional Manufacturer Narrative
Upon completion of the investigation on one of the devices; it was determined that it was not experiencing the issue reduced/inadequate brake force.The count of events has been corrected to reflect this.
Event or Problem Description
This report summarizes (b)(4) malfunction events, where it was reported the devices experienced reduced/inadequate brake force.There was no patient involvement.

• 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: 18574347
• Report Number: 0001831750-2024-00264
• Device Sequence Number: 15723515
• Product Code: FPO
• UDI-Device Identifier: 07613327278149
• UDI-Public: 07613327278149
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/01/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown