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

Catalog Number 650700000000

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that the retractable handle on the device is not locking in position.It was also reported that when users grab the handle to take out the cot, it detaches and the user falls backwards.However, no serious injury or adverse consequences were reported.Attempts are being made to gather additional details from the user facility.

Event Description

It was reported that the retractable handle on the device is not locking in position.It was also reported that when users grab the handle to take out the cot, it detaches and the user falls backwards.However, no serious injury or adverse consequences were reported.

Manufacturer Narrative

A stryker senior specialist, post-market surveillance, reached out to a stryker sales rep about this issue.They confirmed that the unit was repaired for the customer by a third party service and that additional details of the repair are not available.They stated that nothing else is needed from stryker at this time.Based on the investigation, the stryker senior qae determined that the issue of false engagement of wagon handle in the horizontal position was likely due to the foot section: retractable wagon handle latch needing alignment/adjustment.

• Brand Name: POWER PRO 2 AMBULANCE COT
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17932897
• MDR Text Key: 325634112
• Report Number: 0001831750-2023-01027
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327504460
• UDI-Public: 07613327504460
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2023
• 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