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

Catalog Number 6506000000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient has since passed away.The user facility stated that the alleged cot tip did not cause the patient death, as due to the patient's pre-existing condition would have likely passed away if the alleged cot tip had not happened, but that these events may have contributed.

Event Description

It was reported that the cot was being pulled out of the ambulance with a patient who was allegedly properly restrained to the cot.It was reported that the safety bar did not engage within the safety hook.When this happened, the cot tipped to the right and the patient fell to the ground.The (b)(6) patient hit their head, broke their clavicle, and broke several ribs.

Manufacturer Narrative

The evaluation of the device and a labeling review identified that the root cause may be attributed to use error by unloading the cot at an angle or not verifying the safety bar is engaged in the safety hook when attempting to unload the cot.A refresher training on how to properly load/unload the cot from the ambulance and how to properly use the restraints has been scheduled with the user facility.

Event Description

It was reported that the cot was being pulled out of the ambulance with a patient who was allegedly properly restrained to the cot.It was reported that the safety bar did not engage within the safety hook.When this happened, the cot tipped to the right and the patient fell to the ground.The (b)(6) patient hit their head, broke their clavicle, and broke several ribs.

• 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: 7525209
• MDR Text Key: 108610831
• Report Number: 0001831750-2018-00494
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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