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

Model Number 6506

Device Problem Device Tipped Over (2589)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/02/2023

Event Type  Injury  

Event Description

It was reported that the device's wheel was caught in a hole/crack in the pavement, resulting in a cot tip.As a result, the patient bumped their head.A ct scan revealed no impairment.However, the patient received a fractured clavicle from the fall.

• Brand Name: POWER PRO AMBULANCE COT
• Type of Device: AMBULANCE STRETCHER, ELECTROHYDRAULIC
• 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: 16267324
• MDR Text Key: 308410292
• Report Number: 0001831750-2023-00273
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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