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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
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.3 devices were evaluated in the field and the issue was confirmed; 1 had a calibration issue and 2 had a broken/damaged component.The devices were repaired and returned.1 device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 4 malfunction events, where it was reported the scale was inaccurate.There was no patient involvement.
 
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Brand Name
EPIC II CRITICAL CARE BED
Common Device Name
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8280786
Report Number0001831750-2019-00066
Device Sequence Number11152238
Product Code FNL
UDI-Device Identifier07613327348231
UDI-Public07613327348231
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized4
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/28/2019
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
Operator of Device No Information
Device Catalogue Number2030 EPIC
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2019
Initial Report FDA Received Date01/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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