MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; SURGICAL OPERATING TABLE

Model Number 5803

Device Problem Device Slipped (1584)

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

Event Date 06/02/2020

Event Type  malfunction  

Event Description

It was reported "while using an osi spine bed in the supine flat top configuration the mechanics malfunctioned as the circulating team was rotating the patient back to supine from a 5 degree tilt using the remote control.The brake light remained on and was not released prior to the bed malfunction.The anesthesia provider tilted the bed with the remote and it made an odd sound just before the bed pitched.The malfunction of the bed caused the bed to pitch to the right and continue in a downward rotation.The circulating team managed to stop the rotation of the bed and stabilize both the patient and the bed.The patient was not harmed during this event due to 3 support straps that were in place.

Manufacturer Narrative

The medical center is using an allen flat (imaging) top on the 5803 base.No other tops except those manufactured by mizuho osi is certified for use wn a 5803-table base.There is no service history for 5803 table that was purchased in 2012.A review of training records shows no trained / certified personnel at this hospital, the service history for this table is unknown.As stated in the owner's manual section 5.3 preventative maintenance: a pm check on this product is required once every year by a trained service personnel.Also stated in the owner's manual: if the device is excessively or abusively used, the manual rotation locking mechanism and foot-end locking mechanism should be regularly checked to ensure the 95ft/lb torque is maintained.Due to lack of proper maintenance by un-trained/certified personnel, the blue handle torque issue would have been reviewed and adjusted to proper specification thru regularly schedule preventative maintenance by trained and certified personnel and the tilt issue could have been avoided.

Event Description

It was reported "while using an osi spine bed in the supine flat top configuration the mechanics malfunctioned as the circulating team was rotating the patient back to supine from a 5 degree tilt using the remote control.The brake light remained on and was not released prior to the bed malfunction.The anesthesia provider tilted the bed with the remote and it made an odd sound just before the bed pitched.The malfunction of the bed caused the bed to pitch to the right and continue in a downward rotation.The circulating team managed to stop the rotation of the bed and stabilize both the patient and the bed.The patient was not harmed during this event due to 3 support straps that were in place.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 10159460
• MDR Text Key: 200882591
• Report Number: 2921578-2020-00021
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1