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

Catalog Number 6506000000

Device Problems Bent (1059); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 01/22/2017

Event Type  Injury  

Event Description

It was reported by the user facility that while unloading a patient from the ambulance at the hospital there was a weight distribution issue as well as a personnel over lift and device control issue which resulted in the device dropping and tipping over to the patients left side causing patient injury to the facial area and arm.The patient received injuries to the mouth as well as soft tissue injuries noted to the left arm.The hospital staff assisted with transferring the patient to another device from the ambulance bay via use of backboard and manual c-spine stabilization for emergency department evaluation.The user facility stated that the incident was operator error and there is no alleged defect with the device.The device was inspected and a load wheel was found to be bent however this did not allegedly cause or contribute to the 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
• 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: 6341032
• MDR Text Key: 67729438
• Report Number: 0001831750-2017-00041
• 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
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• 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