MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6083 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number	6083000000
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the manual release was not functioning on the device.It was further reported that the patient or user sustained an unspecified injury.Attempts are being made to gather more details from the user facility.
Additional Manufacturer Narrative
As a result of the event, a visual and functional inspection was performed by a stryker field service technician.It was found that the inability to disengage the cot from the fastener was due to the lock bar being bent/deformed likely from pulling a release handle while weight is on the cot or an external force on the outer base tube while unloading the cot without engaging a release handle.In response to the alleged injury, a stryker quality assurance engineer attempted to gather further information regarding the injury, however, the customer did not respond to these attempts.A written letter was sent with a request to contact stryker with additional information on the alleged injury.If this should occur, this investigation may be reopened, and additional details added.
Event or Problem Description
It was reported that the manual release was not functioning on the device.It was further reported that the patient or user sustained an unspecified injury.

• Brand Name: 6083 AMBULANCE COT
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17710722
• Report Number: 0001831750-2023-01000
• Device Sequence Number: 20516078
• Product Code: FPO
• UDI-Device Identifier: 07613327261585
• UDI-Public: 07613327261585
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/12/2024

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: 6083000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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