MAUDE Adverse Event Report: STRYKER MEDICAL SM104 M-SERIES W/5TH WHEEL; STRETCHER, WHEELED

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

The patient was lying on her side on cart.Cart was locked but brakes did not hold, heard brakes release.As cart started to roll away from x-ray equipment pt's legs fell off side of cart and technologist caught pt's upper body and lowered her to the floor.

• Brand Name: SM104 M-SERIES W/5TH WHEEL
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7305742
• MDR Text Key: 101299572
• Report Number: 7305742
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 64 YR