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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC. OOK SNOW; MEDICAL BED
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UMANO MEDICAL INC. OOK SNOW; MEDICAL BED Back to Search Results
Model Number FL36
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2018
Event Type  malfunction  
Event Description
User reported that the bed exit detection system on a medical bed was not functioning properly.There was no adverse consequence to the patient.
 
Manufacturer Narrative
No defects were found.The most probable cause of this situation appears to be that the calibration had not been done by the user and the instructions for zeroing not followed.Therefore, this would be a user error since the indications for calibration and zeroing are mentioned in the accompanying documentation.Precisions were made to the user manuel (corrective action : res 85592 recall 3009591865-04/28/2020-001-c ) to emphasis the preventive maintenance annual checklist, which includes calibration and to emphasis on usage of detection system and the zeroing procedure, which is explained and described in the user manual.The manufacturer will follow the trend.
 
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Brand Name
OOK SNOW
Type of Device
MEDICAL BED
Manufacturer (Section D)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, G0R 2 C0
CA  G0R 2C0
MDR Report Key8190028
MDR Text Key131379493
Report Number3009591865-2018-00025
Device Sequence Number1
Product Code FNL
UDI-Device Identifier00670482000067
UDI-Public010067048200006711161003
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFL36
Device Catalogue NumberFL36
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight45
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