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

Model Number 2141

Device Problem Intermittent Loss of Power (4016)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.45 devices were functionally/visually inspected in the field.These devices were repaired and returned to use.1 device was not made available for inspection by the end user.2 devices are pending investigation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 48 malfunction events, where it was reported the zoom disengages during use.There was no patient involvement.

Manufacturer Narrative

The final 2 devices were evaluated in the field.The issue was confirmed for one device, which was repaired on site and returned to service.The second device was evaluated and it was determined the device experienced a non-reportable issue.

Event Description

This report summarizes 47 malfunction events, where it was reported the zoom disengages during use.  there was no patient involvement.

• 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: 11231209
• MDR Text Key: 228862572
• Report Number: 0001831750-2021-00167
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• Combination Product (y/n): N
• Number of Events Reported: 47
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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: 01/01/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/01/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1