MAUDE Adverse Event Report: STRYKER MEDICAL S3; BED, AC-POWERED ADJUSTABLE

Model Number 3002

Device Problems Failure to Charge (1085); Battery Problem (2885)

Patient Problem Injury (2348)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Multiple complaints about the stryker s3 bed not holding a sufficient charge and creating difficult transport of patients when the battery fails.Healthcare team members report that the bed is heavy and is difficult to push, which creates injuries for the team.In addition there are complaints that the drive function on the bed is too close to the stride of the pusher and causes the pusher to inadvertently hit the driver function and put the bed into neutral.The manufacturer was alerted and replaced the charger on the beds, however there continues to be problems with the design with the neutral/drive pedal being too easy to hit when transporting the bed.Per the hospital, the manufacturer responded to the complaint of the charging unit not holding a charge and replaced the charge inverter.In addition, the manufacturer has been made aware of the design flaw (neutral/drive) function being too close to the feet of the transporter while walking.

• Brand Name: S3
• Type of Device: BED, AC-POWERED ADJUSTABLE
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 7658442
• MDR Text Key: 113022971
• Report Number: 7658442
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3002
• Device Catalogue Number: 3002S3ZOOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1