MAUDE Adverse Event Report: HILL-ROM, INC. STRETCHER; STRETCHER, WHEELED

Device Problems Degraded (1153); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Fail-Safe Did Not Operate (4046)

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

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a manufacturer hill-rom stretcher, serial number unknown that had reduced brake force and a side rail that was loose/wobbly.Please find additional contact information below.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRETCHER
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 17317070
• MDR Text Key: 319074923
• Report Number: MW5119353
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1