MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO FLOOR MOUNT FASTENER SNGL PLT; STRETCHER, WHEELED

Catalog Number	6370000000
Medical Device Problem Codes	Vibration (1674); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer has a locking rail for mass casualty in a transport van that the cot is becoming unlocked from on occasion.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
Event or Problem Description
It was reported that the customer has a locking rail for mass casualty in a transport van that the cot is becoming unlocked from on occasion.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
It was originally reported that an unknown cot was becoming unlocked.Upon completion of the device evaluation by a field service representative, it was found that the 6506 cot was concomitant to this event and the defect was related to the 6370 floor mount fastener.It was reported by the field service representative that the 6370 fastener has vibrations, wobbly or feels loose and shaking during use.This issue is not likely to result in serious injury or death to the patient or caregiver.Section d and h have been updated with correct product information and manufacturing date.

• Brand Name: FLOOR MOUNT FASTENER SNGL PLT
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19777079
• Report Number: 0001831750-2024-00734
• Device Sequence Number: 12829322
• Product Code: FPO
• UDI-Device Identifier: 07613327261622
• UDI-Public: (01)07613327261622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 6370000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 650605550002
• Patient Sex: Unknown