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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
Model Number 2030
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/01/2020
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.2 devices were evaluated in the field and the issue was confirmed; 1 device had a pinched wire and another device had a calibration issue.The devices were repaired and returned.1 device was evaluated in the field and the issue was confirmed.However, there was no product malfunction; the issue was the result of use error as the scale was not properly zeroed before use.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 3 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 Key10321334
Report Number0001831750-2020-00815
Device Sequence Number11407431
Product Code FNL
UDI-Device Identifier07613327348231
UDI-Public07613327348231
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized3
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/24/2020
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 Model Number2030
Device Catalogue Number2030 EPIC
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/01/2020
Initial Report FDA Received Date07/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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