MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Awareness during Anaesthesia (1707); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The patient reported having experienced recall of the surgical procedure.No further information is available at this time.No information has been received indicating the patient experienced any injury as a result of the alleged light anesthesia.

Manufacturer Narrative

When the reported event occurred, the onsite ge biomed was called in to the operating room.Upon arrival, the ge biomed noted an alarm on the ventilator screen that stated absorber panel open.The ge biomed pushed on the absorber panel, clearing the alarm condition.Subsequently, a ge healthcare service representative performed a checkout of the equipment.The following was noted: the tec 6 vaporizer, that was reportedly used during the case, failed the leak test at all settings.Inspection of the equipment noted that both port valve o-rings were missing from the vaporizer manifold.Once the o-rings were installed, the leak test passed.During the ventilator bellows test, the bellows fell more than 100mil/min indicating a leak.The diaphragm and seat assembly was replaced and resolved the leak.

Manufacturer Narrative

The first supplemental report was filed 10 october 2018 to report ge healthcare's investigation results.This supplemental report #2 is being submitted to report additional information received.A third supplemental report will be submitted after investigation into the reported new information has been completed.Device evaluation anticipated, but not yet begun.

Event Description

New information was received alleging serious injury on a malfunction that was reported (b)(6) 2018.The new information alleged physical injury resulting in severe emotional pain and suffering and indicated the patient, suffered severe personal injuries, both mental and physical, and will continue to suffer throughout the duration of her life".

Manufacturer Narrative

This supplemental report #3 is being submitted to provide investigation results after new information was received alleging the patient suffered physical injury resulting in alleged emotional pain and suffering.A ge healthcare service representative performed a checkout of the device.A leak greater than 100 ml/min was found in the breathing system.As a result of this, the diaphragm and seat subassembly, the missing valve port o-rings, and the scavenging system red cap were replaced on the device.Ge healthcare product engineering performed an investigation of this event.The logs that were reviewed as part of this investigation have a boot count that documented the last four bootup cycles.The device was used after the incident for five days until being placed in quarantine.The logs contain the alarms that were present in cases that transpired after the reported awareness since the incident happened on the (b)(6) 2018 and the device was quarantined on the (b)(4) 2018.The device leaks (missing o-rings and diaphragm and seat subassembly) found by the ge healthcare service representative are clinically hazardous because it led to insufficient anesthetic agent being delivered to the patient and the potential for insufficient ventilation.Since the ge healthcare service representative performed checkout on the device and found these issues, it is likely the device contributed to the patient incident and the leaks would have been discovered if the checkout procedure had been followed.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7703693
• MDR Text Key: 114472034
• Report Number: 2112667-2018-01420
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Weight: 159