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

Catalog Number	650705550002
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced inability to disengage the cot from the cot fastener and false engagement of handle in the upright or horizontal position.There was 1 event with patient involvement; the patient experienced unknown.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced false engagement of handle in the upright or horizontal position.There was 1 event with patient involvement; no adverse consequences were reported.
Additional Manufacturer Narrative
The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.The device code was also adjusted per evaluation of the device.Section h codes have been updated to reflect this.

• Brand Name: 6507 POWER PRO 2, MID CONFIG
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19818522
• Report Number: 0001831750-2024-00737
• Device Sequence Number: 8666004
• Product Code: FPO
• UDI-Device Identifier: 07613327559125
• UDI-Public: 07613327559125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 650705550002
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown