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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EPIC II CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL-KALAMAZOO EPIC II CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number 2030 EPIC
Device Problems Bent (1059); False Reading From Device Non-Compliance (1228); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the scale was inaccurate due to the foot right load cell being out of the socket due to a bent frame.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Conclusion: customer does not want to repair bed and will be scrapping it.
 
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Brand Name
EPIC II 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 Key3607423
MDR Text Key4160966
Report Number0001831750-2014-01005
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
Report Date 01/16/2014
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 Other
Device Catalogue Number2030 EPIC
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/16/2014
Initial Date FDA Received02/05/2014
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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