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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Fall (1848)
Date of Event 12/12/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A patient fall was reported to the manufacturer when user placed a call for technical verifications relative to the product.Verifications confirmed the bed was performing to specifications.The establishment nurse call system does not discriminate the priority of signal between the calling bell and the detection system; the bed exit alarm was taken as call bell and the bed exiting resulted in a fall.There were no consequence requiring a medical intervention for the patient.
 
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Brand Name
OOK SNOW
Common Device Name
MEDICAL BED
Manufacturer (Section D)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA  G0R 2C0
MDR Report Key7135664
Report Number3009591865-2017-00005
Device Sequence Number19157708
Product Code FNL
UDI-Device Identifier00670482000067
UDI-Public00670482000067
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Nurse
Device Model NumberFL36
Device Catalogue NumberFL36
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2017
Initial Report FDA Received Date12/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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