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

Model Number	6390
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon investigation and consulting with contact at the account, it was identified that the cot was being loaded into the power load incorrectly.The field service representative provided education for staff on proper device use.
Event or Problem Description
It was reported that a bariatric patient was loaded on a cot and while being loaded into the ambulance, the power load dropped the cot and an employee injured their back.Further information regarding the injury was not provided.
Additional Manufacturer Narrative
It was reported that the user attempted to lift the cot before the fastener completed its ascent with a bariatric patient, resulting in the user suffering a back strain that did not require treatment.Corrected the manufacturing date.
Event or Problem Description
It was reported that a bariatric patient was loaded on a cot and while being loaded into the ambulance, the power load dropped the cot and an employee received a back strain that did not require treatment.

• Brand Name: MTS POWER LOAD
• Common Device Name: 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: 16272596
• Report Number: 0001831750-2023-00276
• Device Sequence Number: 7554581
• Product Code: FPO
• UDI-Device Identifier: 07613327394740
• UDI-Public: 07613327394740
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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 Model Number: 6390
• Device Catalogue Number: 639005550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown