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

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

A fix was proposed to the customer for repair of the unit.

Event Description

The hospital reported that the following parts were damaged and need to be replaced: adjustable pressure limit assembly, sensor interface board, flow sensor, orange o-ring on exchange and condensor module, black o-ring on reusable co2 absorber canister, and o-ring valve port.There was no reported patient involvement.

Manufacturer Narrative

Due to additional information received, ge healthcare has determined the event was not reportable.There was no loss of ventilation.Regarding the reported flow sensor issue: flow sensors are a customer replaceable item.The unit continues to ventilate and alarms remain functional.The clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.Regarding the reported adjustable pressure limit (apl) issue: the reported complaint will be noted during preuse testing, as contained in the user manual.The pressure gauge has been designed as a means for the clinician to monitor pressure in the circuit.Th unit is designed to alarm if pmax setting is reached.The user has the option to switch to mechanical mode of ventilation where the apl is not in the circuit.Regarding the sensor interface board issue: unit continues to ventilate and alarms remain functional.The clinician has the option to switch to the bag position to manually ventilate the patient if mechanical ventilation is in question.

• Brand Name: AESPIRE 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 6011413
• MDR Text Key: 56810436
• Report Number: 2112667-2016-01964
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K050626
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2016
• 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