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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO IN TOUCH ZU; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO IN TOUCH ZU; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 2141000000
Device Problem Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the bed allegedly smelled like plastic burning and/or a hot motor.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted with evaluation results in which no burnt smell was detected on the bed at time of evaluation.During evaluation, it was found the batteries were not holding a charge and the footboard had no display.Batteries not charging is not likely to harm the patient as the only bed function that requires the battery is the zoom.The bed can be moved manually by the caregiver.The footboard display not functioning is not likely to harm the patient as bed motor functions are still available on the siderails and functions that are only available on the footboard, such as bed exit and scale, would be clearly indicated that they are unavailable.No patient was affected and no adverse consequences or clinically relevant delays in treatment were reported.This issue is not likely to contribute to or cause serious injury or death if it were to recur.
 
Event Description
It was reported via repair work order that the bed allegedly smelled like plastic burning and/or a hot motor.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
IN TOUCH ZU
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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3637476
MDR Text Key4433271
Report Number0001831750-2014-01519
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2141000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/27/2014
Was Device Evaluated by Manufacturer? Yes
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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