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

Catalog Number	6506000000
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Abrasion (1689); Hematoma (1884); Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screws on the device's wheels snapped and caused the cot to fall down to the ground.It was additionally reported that the patient fell off of the cot and was injured.
Event or Problem Description
It was reported that the screws on the device's wheels snapped and caused the cot to fall down to the ground.It was additionally reported that the patient fell off of the cot and was injured.
Additional Manufacturer Narrative
The issue was identified to be with the cot and not the powerload, which is now identified to be the concomitant device.It was reported by the customer that allegedly the cot wheels snapped and the cot fell, injuring the patient.As a result of the injury, a stryker sr.Qae contacted the customer for further information.The customer stated that, while two users were unloading the cot, the cot load wheels broke.This resulted in a hematoma to the patient's hand and a skin injury to the leg and foot.The patient then was evaluated in the emergency department.No further treatment information was provided.As a result of the event, a visual and functional inspection was performed by a stryker field service technician.It was found that the unintended cot drop was due to the head section retractable assembly being broken/damaged.The issue was resolved for the customer by replacing the head section of the device.

• Brand Name: POWER-PRO XT
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19209313
• Report Number: 0001831750-2024-00689
• Device Sequence Number: 12744388
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: (01)07613327261523(21)180640848
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/11/2024

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 Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2018
• 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