MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO ARM; HEAD POSITIONING

Model Number 7887-050

Device Problems Electrical Shorting (2926); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

Event Description

It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.

Manufacturer Narrative

The cause of the unintended motion was a short circuit of the control circuit due to fluid ingress.Fluid ingress path appears to have originated from around the upper release button at the control handle.This fluid caused a temporary short circuit.During inspection the fluid had dried out and the short circuit was not measurable.

Event Description

It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.

Manufacturer Narrative

The cause of the unintended motion was a short circuit of the control circuit due to fluid ingress.Fluid ingress path appears to have originated from around the upper release button at the control handle.This fluid caused a temporary short circuit.During inspection the fluid had dried out and the short circuit was not measurable.

Event Description

It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.

• Brand Name: LEVO ARM
• Type of Device: HEAD POSITIONING
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8664256
• MDR Text Key: 146846625
• Report Number: 2921578-2019-00022
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7887-050
• Device Catalogue Number: 7887-050
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2921578-10/16/2019-001-R
• Patient Sequence Number: 1