MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Catalog Number 650705550001

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that the device's wagon handle falsely released, while the caregiver was moving the patient.The caregiver sustained an injury to the shoulder and was evaluated.Treatment received is currently unknown.Attempts are being made to gather additional details from the use facility.

Manufacturer Narrative

A visual and functional inspection was performed by a stryker field service technician.It was found that the issue of the wagon handle disengaging was not due to any component level defect as it could not be duplicated.A stryker senior quality assurance engineer reached out to the account for details on the reported injury.He stated that the caregiver was pulling the cot up a ramp when the wagon handle released.He additionally stated that the caregiver injured their shoulder.He was evaluated and released shortly afterwards.He did not have additional details surrounding the injury and treatment provided.This issue was resolved for the customer by ensuring functionality of the unit and that nothing else was needed from stryker.

Event Description

It was reported that the device's wagon handle falsely released, while the caregiver was moving the patient.The caregiver sustained an injury to the shoulder and was evaluated.Treatment received is unknown.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18610484
• MDR Text Key: 334139234
• Report Number: 0001831750-2024-00295
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327559118
• UDI-Public: 07613327559118
• 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,Followup
• Report Date: 04/23/2024

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: 650705550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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