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

Model Number INTOUCH FL24 ZOOM DRIVE

Device Problems Positioning Failure (1158); Material Twisted/Bent (2981)

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

Event Date 08/07/2019

Event Type  malfunction  

Event Description

Biomed dept received call that bed does not go down all the way.Bed was inspected and was found to have a bent pin.Pin and brass catches were adjusted.Not sure of root cause of why bed was bent.Typically see where the bed is lower than a wall rail and could have been raised causing the potential failure.

• Brand Name: INTOUCH
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 9255702
• MDR Text Key: 164300002
• Report Number: 9255702
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: INTOUCH FL24 ZOOM DRIVE
• 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: 09/20/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1