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

Model Number 2141

Device Problem Alarm Not Visible (1022)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the malfunction summary reporting program, exemption number e2014007.The devices were evaluated in the field and the issue was confirmed.The devices had malfunctioned electrical components.There were no remedial actions taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the ibed awareness was not alarming.One event had no patient involvement.One event it was not known if there was 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
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7465694
• MDR Text Key: 106872988
• Report Number: 0001831750-2018-00431
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: (01)07613327169232
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2141
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2018
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1