MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MX-PRO R-3 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number 6082000000

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 10/07/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the injured emt went to the doctor for the knee injury and received an mri which showed that they had a tear in their meniscus and joint effusion (fluid in joint) as a result of the tear.It was reported that the emt was placed on light duty.The patient was not reported to have been injured during this event.

Event Description

It was alleged that two emt's were loading a bariatric patient into the ambulance.The emt that was located at the foot end of the cot allegedly pulled the release lever and the legs were retracted.When the emt at the foot end attempted to release the lever, the lever allegedly stuck and would not go back to the locked position.It was alleged that since the cot would not latch and the patient was heavy, the cot allegedly dropped.When this occurred, the emt lifted their knee to brace the cot and received a knee, lower back, and hip injury.

Manufacturer Narrative

A visual and functional inspection was performed by a stryker field service representative.It was identified that no defects or malfunctions were identified that would have caused or contributed to the alleged event and that the alleged event could not be duplicated.This issue was resolved for the customer by inspecting the device, ensuring proper functionality, and returning the device to service.

Event Description

It was alleged that two emt's were loading a bariatric patient into the ambulance.The emt that was located at the foot end of the cot allegedly pulled the release lever and the legs were retracted.When the emt at the foot end attempted to release the lever, the lever allegedly stuck and would not go back to the locked position.It was alleged that since the cot would not latch and the patient was heavy, the cot allegedly dropped.When this occurred, the emt lifted their knee to brace the cot and received a knee, lower back, and hip injury.

• Brand Name: MX-PRO R-3 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: 6996683
• MDR Text Key: 90893155
• Report Number: 0001831750-2017-00499
• Device Sequence Number: 1
• Product Code: FPO
• 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,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6082000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2009
• 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