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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ZOOM CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO ZOOM CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 2040000000
Device Problems Failure to Charge (1085); Improper or Incorrect Procedure or Method (2017)
Patient Problem Fall (1848)
Event Date 03/02/2014
Event Type  Injury  
Event Description
It was reported that the bed was unplugged for several hours and allegedly a patient fell out of the bed.Batteries were replaced because the bed was unplugged so long they would not take a charge.Nurse reported that she has instructed her nurses to plug in beds and not leave unplugged for extended periods of time.There was patient involvement; however, no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
ZOOM CRITICAL CARE BED
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 Key3736899
MDR Text Key4310783
Report Number0001831750-2014-02871
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 Other,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number2040000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/17/2014
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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