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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 5700
Device Problems Failure to Zero (1683); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  malfunction  
Event Description
It was reported by service report that the scale was inaccurate due to the bed not being zeroed properly.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was initially reported the scale was inaccurate due to the bed not being zeroed properly; however, this was reported in error.The scale was inaccurate due to a malfunctioned load cell.
 
Event Description
It was reported by service report that the scale was inaccurate due to a malfunctioned load cell.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
SPIRIT SELECT
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
1020 adelaide st. s.
N6E 1 R6
CA  N6E 1R6
MDR Report Key7336406
MDR Text Key102465931
Report Number3006433555-2018-00067
Device Sequence Number1
Product Code FNL
UDI-Device Identifier07613327284546
UDI-Public(01)07613327284546
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5700
Device Catalogue Number5700000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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