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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
Catalog Number 5700000000
Device Problem Device Tipped Over (2589)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device is pending evaluation.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device tipped over.There was no patient involvement.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device tipped over.There was no patient involvement.
 
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; it was found the unit had tipped over during transport, resulting in the bed frame becoming damaged.The unit was scrapped.There was no remedial action taken.This device is not labeled for single use.
 
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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 Key8283535
MDR Text Key134326133
Report Number3006433555-2019-00008
Device Sequence Number1
Product Code FNL
UDI-Device Identifier07613327284546
UDI-Public07613327284546
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5700000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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