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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Unavailable as not reported on anonymous maude report.Serial number not provided.Report source other: maude report #(b)(4).Date of device manufacture unknown as no serial number provided.A brand new anesthesia machine was put into electrophysiology procedure lab (aisys) to replace the old tiro this morning.The new machine failed in the middle of a sedation case during the afternoon.The top monitor with vs was still working, but i had no end tidal co2.All plugs were checked and were plugged in.Also, the machine was turned on and off and would not reboot.Biomed was called stat to the room and could not solve the problem.The patient was fine throughout, and we were able to finish the case.It would have been nice to have been able to monitor end tidal off of the lifepak but we did not have the correct adaptor needed to do so.End-tidal co2 was monitored with my hand (breathing) and o2 saturation (pulse ox of 100%) for the rest of the case.We decided not to change out the machine since we would have had to disconnect all of the monitors and would lose vital signs totally during that switch out.The subcutaneous implantable cardioverter-defibrillator was not tested during this anesthetic.We decided it would be too risky to induce ventricular fibrillation without the appropriate anesthesia equipment available (gas machine).The patient is scheduled to come back to have her defibrillator tested.

Event Description

The hospital reported via anonymous maude report that the unit had a loss of mechanical ventilation.There was no report of patient injury.

• Brand Name: AISYS
• 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: 10071742
• MDR Text Key: 220694839
• Report Number: 2112667-2020-01496
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/19/2020
• 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: N
• Patient Sequence Number: 1