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

Model Number 883

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  malfunction  

Event Description

Registered nurse was asked to raise the height of bed (hob) on the gurney.When she squeezed the handle to bring the hob up, the hob fell back to a completely supine position with patient on the gurney.

• Brand Name: GPS STRETCHER
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 10133413
• MDR Text Key: 194495074
• Report Number: 10133413
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 883
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 84