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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO ARM; HEAD POSITIONING UNIT
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MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO ARM; HEAD POSITIONING UNIT Back to Search Results
Model Number 7887-050
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Root cause is determined to be a short circuit caused by corroded electrical contacts within an in-line connector.
 
Event or Problem Description
We had a case this morning using it for the first time and after the case when i was putting the levo arm away i noticed that all of a sudden it could be engaged with pressing only one button instead of both the dark blue and baby blue at the same time.Shortly after it would work normally with both buttons pressed as it should.
 
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Brand Name
LEVO ARM
Common Device Name
HEAD POSITIONING UNIT
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city, ca
MDR Report Key10048418
Report Number2921578-2020-00016
Device Sequence Number19545132
Product Code JEA
UDI-Device Identifier00842430104992
UDI-Public00842430104992
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date (Section B) 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number7887-050
Device Catalogue Number7887-050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/19/2019
Initial Report FDA Received Date05/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		2921578-10/16/2019-001-R
Patient Sequence Number1
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