MAUDE Adverse Event Report: MIZUHO OSI JACKSON SPINE TABLE; OPERATING TABLE

Model Number	7943
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature citation: literature citation: kim, ji hyun mda,*; kim, sora mda; yu, taeyoung mda; yang, woo seok mda; hong, seong wook mda.Sudden arrhythmia in the prone position during spinal surgery: a case report.Medicine: august 19, 2022 - volume 101 - issue 33 - p e30137.Doi: 10.1097/md.0000000000030137.Following the retrospective analysis of the report, the reason for the patient's chest to be stressed enough to develop arrhythmia remained unclear.It is indicated by the author that jackson spine table has the least effect on hemodynamic circulation, but they suspect that using a transverse pad might have contributed to arrhythmia.Since there is no event of arrhythmia reported before, we agree with the author's conclusion that the reason for arrhythmia was unclear.Authors suggest that longitudinal vs transverse pads might influence such occurrences based on patients' habitus.
Event or Problem Description
Literature citation: kim, ji hyun mda,*; kim, sora mda; yu, taeyoung mda; yang, woo seok mda; hong, seong wook mda.Sudden arrhythmia in the prone position during spinal surgery: a case report.Medicine: august 19, 2022 - volume 101 - issue 33 - p e30137 doi: 10.1097/md.0000000000030137.A 155 cm, 59 kg, 70-year-old woman with spinal stenosis was undergoing transforaminal lumbar interbody fusion using the jackson spine table (mizuho osi).A sudden cardiac arrhythmia occurred approximately 30 minutes after moving to the prone position and continued for 10 to 30 seconds following spontaneous restoration to normal sinus rhyhm for a few minutes after positional change to the supine position.Hence, increased intrathoracic pressure caused by the prone position was highly suspected to be the cause of this event.It was difficult to exactly define the type or cause of the sudden arrhythmia and considering that other vital signs remained stable, a close observation was kept during the length of the operation rather than applying uncertain antiarrythmic medication.Although the jackson spine table (mizuho osi) is known to have the least effect on cardiac function, arrhythmia was observed in the patient in this case.

• Brand Name: JACKSON SPINE TABLE
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern aveue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15547696
• Report Number: 2921578-2022-00020
• Device Sequence Number: 11242551
• Product Code: JEA
• UDI-Device Identifier: 00842430103971
• UDI-Public: 00842430103971
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

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: Health Professional
• Device Model Number: 7943
• Device Catalogue Number: 7943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian