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

Model Number 6390

Device Problem Device Fell (4014)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 09/09/2021

Event Type  Injury  

Event Description

It was reported that the part that picks up the cot and loads the cot was broken and wasn't allowing the cot to lock into place and load properly.When off loading the cot, the emt had forgotten that the mechanism was not attached and the emt caught the cot as it was pulled out.It was reported the emt pulled a muscle in their back the emt was treated by their primary doctor, cts did not find any acute injuries, however the emt took time off work.It is unknown if the emt took any medication.

• 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: 13024555
• MDR Text Key: 282382068
• Report Number: 0001831750-2021-01651
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113598
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6390
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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
• Patient Outcome(s): Other