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

Model Number 1006-9310-000

Device Problem Improper Flow or Infusion (2954)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/22/2021

Event Type  Injury  

Event Description

Per medwatch report # mw5109273: "following intubation and prior to start of surgery in the ep lab, the ge aestiva anesthesia machine was unable to manually ventilate patient in the bag mode.Bag was distended but no chest rise observed when squeezed.Pt spo2 values decreased for period of 4 minutes, until machine was able to ventilate in mechanical ventilation mode.The intervention required to prevent permanent impairment/ damage at this point is that an ambu-bag had to be used to deliver oxygen to the pt.Next, the machine was reconnected to the pt, and successfully ventilated the pt.In mechanical ventilation mode.The other serious or important medical event was that the procedure was cancelled as a result of the desaturation event.Pt was not found to have sustained any neurological damage as a result of event, was discharged from hospital, and procedure was successfully performed 10 days later." ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Ethnicity and race: information not available.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The hospitalâs biomedical engineering staff found no evidence of device malfunction, and the device was returned to service after testing.The root cause of the loss of manual ventilation cannot be determined, though it is possible that a patient circuit occlusion contributed, and that the occlusion was resolved prior to ventilation with the ambu-bag or when the patient was reconnected to the aestiva mri and mechanical ventilation was resumed.The hospitalâs biomedical engineering staff found no evidence of device malfunction, and the device was returned to service after testing.The root cause of the loss of manual ventilation cannot be determined, though it is possible that a patient circuit occlusion contributed, and that the occlusion was resolved prior to ventilation with the ambu-bag or when the patient was reconnected to the aestiva mri and mechanical ventilation was resumed.

• Brand Name: AESTIVA MRI
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 14712230
• MDR Text Key: 294132121
• Report Number: 2112667-2022-01624
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1006-9310-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Date Device Manufactured: 10/15/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 105 KG