MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

Catalog Number 6390000000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 09/12/2016

Event Type  Injury  

Event Description

It was alleged that when unloading the power load, the crew member did not realize the power load was in manual mode and was not ready to accept the weight of the devices.The crew member was able to catch the devices from falling; however, this event did result in the medic receiving a strain.As a precautionary measure the crew member was checked into a hospital however no tears or damage were identified and the medic was placed on light duty.

• Brand Name: POWER LOAD
• 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: 6023461
• MDR Text Key: 57189490
• Report Number: 0001831750-2016-00313
• 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: 09/13/2016

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?: No
• Device Operator: No Information
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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
• Treatment: 6506000000 POWER PRO AMBULANCE COT