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

Model Number 2141

Device Problems Unintended System Motion (1430); Intermittent Loss of Power (4016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

It was reported there was an unexpected loss of zoom function.There are no reports of patient involvement or adverse consequences.

Manufacturer Narrative

It was originally reported the device had unexpected loss of zoom function but after investigation it was determined the device was not losing zoom functionality but had un-commanded brake motion.B5 and h codes have been updated to match these investigation results.

Event Description

It was reported the unit had un-commanded brake motion where it would toggle between brake, drive, and neutral.There are no reports of patient involvement or adverse consequences.

• 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: 11197459
• MDR Text Key: 227733451
• Report Number: 0001831750-2021-00074
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2141
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1