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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SELECT, CDN, HI RAILS, CPR, EXT, AUX; BED, AC-POWERED ADJUSTABLE HOSPITAL
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STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SELECT, CDN, HI RAILS, CPR, EXT, AUX; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Catalog Number N3F02CEM
Device Problem Device Tipped Over (2589)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device experienced a tip.There was patient involvement; no adverse consequences were reported.
 
Manufacturer Narrative
The final device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device experienced a tip.There was patient involvement; no adverse consequences were reported.
 
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Brand Name
SELECT, CDN, HI RAILS, CPR, EXT, AUX
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 Key12238432
MDR Text Key263826698
Report Number3006433555-2021-00036
Device Sequence Number1
Product Code FNL
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 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberN3F02CEM
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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