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

Catalog Number	6390000000
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device user experienced a complete power load hydraulic failure while loading a patient into the back of an ambulance.This failure caused the power load and stretcher (xt) to give way.Fortunately, the crew managed to support the stretcher, preventing the patient from falling to the floor.Although the patient was uninjured, the crew experienced some strain on their backs.
Event or Problem Description
It was reported that the device user experienced a complete power load hydraulic failure while loading a patient into the back of an ambulance.This failure caused the power load and stretcher (xt) to give way.Fortunately, the crew managed to support the stretcher, preventing the patient from falling to the floor.Although the patient was uninjured, the crew experienced some strain on their backs.
Additional Manufacturer Narrative
In response to the alleged injury, attempts were made to gather further information regarding the injury, event details, and serial number, however, the customer did not respond to these attempts.

• Brand Name: 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: 19560619
• Report Number: 0001831750-2024-00719
• Device Sequence Number: 17327001
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6506000000 POWER-PRO X; 6506000000 POWER-PRO XT
• Patient Sex: Unknown