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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO IN TOUCH ZX; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO IN TOUCH ZX; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 2140000000
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
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.One device had a calibration issue; 1 device had an electrical issue.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 zoom would disengage during use.No patients were involved.
 
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Brand Name
IN TOUCH ZX
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 Key7453597
MDR Text Key106262866
Report Number0001831750-2018-00317
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number2140000000
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2018
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 Number1
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