MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Catalog Number	6100003000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Head Injury (1879); Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device tipped over during transport between ambulance and hospital.There was a single operator at the foot end, who attempted to catch the cot and restrain patient during the tip.It was further reported that both the patient and paramedic were assessed for injuries at the hospital.The patient was assessed for a head injury, and the user was assessed for an arm injury, both as a result of the incident.
Additional Manufacturer Narrative
It was reported to stryker by the customer that allegedly the cot tipped over during transport between ambulance and hospital.There was an operator at the foot end of the cot who attempted to catch the cot and restrain the patient while the cot tipped.In response to reported injuries, a stryker key account manager reached out to the customer to gather further details about the injury and treatment provided.The customer confirmed that the patient had sustained a head injury, while the paramedic experienced an arm injury.Both individuals were medically evaluated at the hospital; however, additional details regarding the nature and extent of the injuries were unavailable.The customer confirmed that no fatalities occurred.No further injury/treatment information was available.A visual and functional inspection of the cot was performed by stryker pro care services.It was found that the unstable cot leading to tip was not due to any component level malfunction with the unit.The issue was resolved for the customer by verifying full functionality of the unit and confirming that no action is needed from stryker.
Event or Problem Description
It was reported that the device tipped over during transport between ambulance and hospital.There was a single operator at the foot end, who attempted to catch the cot and restrain patient during the tip.It was further reported that both the patient and paramedic were assessed for injuries at the hospital.The patient was assessed for a head injury, and the user was assessed for an arm injury, both as a result of the incident.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• 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: 19613647
• Report Number: 0001831750-2024-00722
• Device Sequence Number: 6018354
• Product Code: FPO
• UDI-Device Identifier: 07613327261530
• UDI-Public: (01)07613327261530(21)110540196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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?: No
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2011
• 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