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

Model Number 6506

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/08/2021

Event Type  Injury  

Event Description

It was reported that while a patient was being transported in an ambulance on a stryker cot, the ambulance was involved in a collision.The patient was properly restrained to the cot at the time of the collision and sustained a broken clavicle as a result of the impact.There was no device malfunction or defect related to the broken clavicle.No additional details regarding the injury or treatment have been provided at this time.The user facility will provide more information as it becomes available.

Manufacturer Narrative

Investigation is complete.B5 and h codes updated to match investigation results.

Event Description

It was reported that while a patient was being transported in an ambulance on a stryker cot, the ambulance was involved in a collision.The patient was properly restrained to the cot at the time of the collision and sustained a broken clavicle as a result of the impact.There was no device malfunction or defect related to the broken clavicle.A post-accident visual and functional inspection was performed and it was found that there were no defects as a result of the accident.

• Brand Name: POWER PRO AMBULANCE COT
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12020593
• MDR Text Key: 256838850
• Report Number: 0001831750-2021-00957
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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 Operator: No Information
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other