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

Device Problems Increase in Pressure (1491); No Flow (2991)

Patient Problem No Code Available (3191)

Event Date 10/07/2018

Event Type  Injury  

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.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, during a case, the clinician switched to mechanical ventilation.It was subsequently noted that no gas was being delivered to the patient.It is further alleged that high pressure was being delivered to the patient.Following the case, the patient was admitted to the nicu.

Manufacturer Narrative

The hospital made two allegations which cannot occur simultaneously: a leak preventing ventilation of the patient and high pressure in the patient circuit.Based on review of the device logs, there is no indication the anesthesia machine delivered high pressure to the patient.The presence of the "low paw" alarm, together with the "bellows collapsed" alarm, indicate a leak in the patient circuit.During the checkout of the equipment, it was noted that the expiratory flow sensor diaphragm was stuck to the top of the flow sensor housing.This condition does not result in high pressure.Pressure is monitored by the patient airway transducer which is independent of the flow sensors.The tv not achieved alarm is consistent with the faulty flow sensor or a leak.There were no alarms present which would indicate high pressure.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8018827
• MDR Text Key: 125454517
• Report Number: 2112667-2018-02153
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1