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

Catalog Number 2141000000

Device Problem Unintended System Motion (1430)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 06/23/2020

Event Type  Injury  

Event Description

It was alleged an employee was pinned against the wall when the zoom function failed to stop on a bed.The customer reports the employee was injured as a result but no additional information has been provided regarding the severity or treatment of the injury.The user facility was unable to provide the model or serial number of the unit.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.

Manufacturer Narrative

The user facility was able to provide the model number of the device involved, but did not respond back to attempts to obtain the serial number or further information regarding the reported malfunction and injury.User facility did not respond to attempts to evaluate the device.

Event Description

It was alleged an employee was pinned against the wall when the zoom function failed to stop on a bed.The customer reports the employee was injured as a result but no additional information has been provided regarding the severity or treatment of the injury.The user facility was unable to provide the serial number of the unit.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10482557
• MDR Text Key: 205295165
• Report Number: 0001831750-2020-00894
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other