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

Model Number 5943

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Literature citation: oydanich, m., naftalovich, r., & iskander, a.(2022).Respiratory decompensation with proning - when prone positioning can worsen respiratory mechanics.Anaesthesiology intensive therapy, 54(2), 187-189.Https://doi.Org/10.5114/ait.2022.113730.Following the retrospective analysis of the case study, no malfunctioning of the device is indicated and the exact reason for respiratory decompensation observed in the patient remained unclear.Author also indicates that despite prone positioning has shown to improve the respiratory function, sustained thoracic damage and lung injury leading to pleural effusion and atelectasis might have contributed to worsening of patient's respiratory status.Based on the investigational review of internal post-market surveillance data, there were no complaints found with incidents related to respiratory decompensation.Multiple warnings regarding personnel training focused on placement of chest pads and its application techniques along with patient positioning for surgery are outlined in the product instructions for use (ifu).As these techniques are manufacturer's suggested techniques, the final disposition of each patient's care as related to use of this equipment rests with the attending surgeon.The case study seeks connection between respiratory function and prone positioning during spinal surgery and multiple studies evaluating this phenomenon have been cited within the article which indicate both positive and negative impacts of prone positioning on respiratory function, depending on patients' anatomy, state of health and other factors.Considering this patient's significant challenges, extra vigilance and careful communication should be warranted in order to ensure safe prone positioning before surgery.

Event Description

Literature citation: oydanich, m., naftalovich, r., & iskander, a.(2022).Respiratory decompensation with proning - when prone positioning can worsen respiratory mechanics.Anaesthesiology intensive therapy, 54(2), 187-189.Https://doi.Org/10.5114/ait.2022.113730.We present a case of a 48-year-old man (weight: 90.2 kg, height: 180 cm) with no significant past medical history, who sustained severe trauma as a passenger following vehicular impact at highway speed.The patient experienced several thoracic injuries, including bilateral rib fractures, tension pneumothorax, pulmonary contusions, haemothorax, lung lacerations, and air leak.Such injuries cause significant deformity of the pulmonary structure and vasculature.The tension pneumothorax and subsequent haemothorax were treated with two chest tubes but the sustained lung tissue injury led to significant pleural effusion and atelectasis, which worsened the patient's respiratory status.Additionally, the patient sustained atlanto-occipital and atlanto-axial dislocation requiring surgical fusion of c2, which is the setting of this report.The patient presented for the c2 fusion surgery intubated and mechanically ventilated.The patient was transported to the operating room from the icu with peep ventilation.Once in the operating room arterial blood gas (abg) analysis revealed a pao2 of 100 mmhg on 60% fio2 and subsequent repeat baseline abg before commencing surgery showed worsening hypoxaemia with a pao2 of 91 mmhg on 100% fio2.Given the surgical urgency, a decision was made by the anaesthesia and orthopaedic teams to proceed despite the suboptimal respiratory status.The patient was positioned from the supine to prone position on a jackson table (mizuho, tokyo, japan).Initially the patient tolerated the prone position with spo2 of 100%.However, roughly 10 minutes after the repositioning, the spo2 began to fall gradually to a nadir of 78%.Manual peep via bag ventilation was utilised while adequate ventilation was confirmed with bronchoscopy which confirmed airway patency and removed minimal secretions.The hypoxaemia did not resolve with hand ventilation and spo2 over 80% was not achievable.A decision to abort the procedure was made and the patient was re-positioned in the supine position.Interestingly, shortly after the repositioning the patient's spo2 quickly returned to 100%.Postoperative chest x-ray revealed worsening pleural effusion and associated atelectasis.Over the next three days, the patient's status gradually improved.One of the patient's two chest tubes was removed and a subsequent chest x-ray showed improvement of the pleural effusion and atelectasis.It was at this time that spinal fusion surgery was attempted again and was completed successfully with less desaturation with proning and a spo2 nadir of 92% and with no further complications.

• Brand Name: JACKSON TABLE
• Type of Device: 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 ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15580435
• MDR Text Key: 301559217
• Report Number: 2921578-2022-00021
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 90 KG