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

Model Number 3002S3EX

Device Problems Bent (1059); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

Stryker s3 beds: we have noted the sheet metal panel under the head/foot ends of the mattress has been found bent with sharp tears to the metal.Biomed has had to file and straighten the sheet metal, however we feel this is unacceptable and potential rusted metal could lead into an infection control problem.This was reported prior to stryker, but we are still unclear on status of recalls or service bulletins that cover the problem.

• Brand Name: STRYKER SECURE S3
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002 582
• MDR Report Key: 4071072
• MDR Text Key: 4742492
• Report Number: 4071072
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 3002S3EX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2014
• Patient Sequence Number: 1