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

Model Number 6506

Device Problem Device Tipped Over (2589)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

It was reported that while unloading a patient who weighed about (b)(6) lb, the cot flipped over.The user facility suggested that this may have been due to the base of the cot hanging up on ambulance bumper.No defect was identified with the cot upon completion of the device evaluation.The user facility did not report an injury to the patient, however there was an injury to a user.Further information was not reported.

Event Description

It was reported that while unloading a patient who weighed about 640lb, the cot tipped over.No defect was identified with the cot upon completion of the device evaluation.The user facility did not report an injury to the patient, however there was an injury to a user.

Manufacturer Narrative

The user facility confirmed that the tip was a result of the patient shifting their weight as the cot was being pulled from the ambulance and was not related to a malfunction of the product.The user facility reported that a caregiver suffered a scrape on their leg as a result of the event with no treatment reported.The patient was not injured during this event.

• 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: 10062473
• MDR Text Key: 191156018
• Report Number: 0001831750-2020-00625
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other