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

Catalog Number 6506000000

Device Problems Component Falling (1105); Device Tipped Over (2589); Mechanical Jam (2983)

Patient Problems Contusion (1787); Physical Entrapment (2327); Injury (2348)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The patient allegedly hit their head on the ground and that their body is sore, although this could not be confirmed and no further details were provided for the patient injury.The trainee allegedly had contusions on some of their fingers, went to an occupational health facility for a precautionary x-ray and was released.The trainee allegedly did ice their fingers, however it is unknown if medications were prescribed.

Event Description

It was alleged that 2 emts and 1 trainee were unloading the cot and patient from the ambulance at the hospital.The 3 members of the crew allegedly pulled the cot out of the ambulance, lowered the legs of the cot, and the legs of the cot allegedly would not hold the weight of the cot.The crew then decided to attempt to lower the cot manually to the ground, so the trainee allegedly went inside the ambulance to lift the safety bar over the safety hook.When the trainee did this, their hand allegedly got caught between the safety bar and the ambulance floor and the 2 emts allegedly could no longer move the cot in or out of the ambulance.Allegedly, as a result, the cot tipped to the left and landed on the ground on its side with the patient still secured by the restraints.The emts then allegedly attempted to turn the cot to a flat position but were unable to and needed to cut the restraints so the patient could be loaded onto a wheel chair to enter the hospital.

• 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: 7320693
• MDR Text Key: 101977572
• Report Number: 0001831750-2018-00134
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: (01)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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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