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

Model Number 6506

Device Problem Device Tipped Over (2589)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 01/08/2022

Event Type  Injury  

Event Description

It was reported that the foot end bracket screws fell out causing the foot end bracket to "hang" freely, resulting in the cot tipping with a patient.It was reported that the cot tip lead to the patient fracturing their arm and receiving lacerations.The patient was treated at the hospital for the injuries, treatment information was not provided.

• Brand Name: POWER PRO AMBULANCE COT
• Type of Device: 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: 13386497
• MDR Text Key: 284651788
• Report Number: 0001831750-2022-00245
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2022

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 Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other