MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO 2 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number	650700000000
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the devices experienced fowler cannot be lowered or 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
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
2 devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.1 device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.Section h codes have been updated.Because of this, the number of reported events has been changed from 4 to 3.1 device is still pending evaluation.
Event or Problem Description
This report summarizes 3 malfunction events, where it was reported the devices experienced fowler cannot be lowered or 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.Section h codes have been updated to reflect this.
Event or Problem Description
This report summarizes 3 malfunction events, where it was reported the devices experienced fowler cannot be lowered or false engagement of handle in the upright or horizontal position.There was 1 event with patient involvement; no adverse consequences were reported.

• Brand Name: POWER PRO 2 AMBULANCE COT
• 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: 19850319
• Report Number: 0001831750-2024-01032
• Device Sequence Number: 6482493
• Product Code: FPO
• UDI-Device Identifier: 07613327504460
• UDI-Public: 07613327504460
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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: 650700000000
• 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; 07/01/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/10/2024
• 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