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); Sprain (2083)

Event Date 02/13/2020

Event Type  Injury  

Event Description

It was reported that a patient was being unloaded from the ambulance.The patient was in the seated position with the fowler up and restrained by all cot restraints.The customer alleges there were two operators on the cot both on the head end of the cot.The customer stated that the patient was larger and shifted their weight to the patient left side and the cot tipped to that side.Allegedly the patient broke their wrist and an operator received a wrist sprain as a result of this incident.The cots safety bar remained caught on the safety hook of the ambulance and prevented the cot from hitting the floor.

• 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: 9813435
• MDR Text Key: 182805711
• Report Number: 0001831750-2020-00311
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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): Required Intervention