MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ADVANTAGE SERIES 29 OBS10/04; STRETCHER, WHEELED

Catalog Number 1501000000

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that the device's brakes were not working.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.Attempts are being made to gather additional details from the user facility.

Event Description

It was reported that the device had reduced/inadequate brake force.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The device was identified, and the correct model number, serial number, and manufacturing date were added.Reportability was also updated.The investigation has been completed.It was reported to a stryker field service technician that the brakes are not working on the stretcher.A work order was opened to capture the alleged complaint of reduced/inadequate brake force.However, the alleged issue was unable to be identified as the parts to repair the unit are no longer available.This unit was not evaluated by a stryker technician, and the wo has been canceled.The issue was resolved for the customer by notifying the customer that the parts needed to conduct the repair are no longer able to be ordered.It was recommended that the unit be scrapped.

• Brand Name: ADVANTAGE SERIES 29 OBS10/04
• 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: 18173079
• MDR Text Key: 328562331
• Report Number: 0001831750-2023-01344
• Device Sequence Number: 1
• Product Code: FPO
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1501000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/1998
• 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