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

Device Problems Failure to Cycle (1142); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

The clinician reported that, at the start of a nuss bar case, when switching from manual mode to mechanical ventilation, the unit alarmed for high pressure.It was reported that the ventilation mode was pressure control with a pressure setting in the teens.The clinician reportedly removed the patient from the anesthesia machine, and connected the machine to a test lung.The clinician reportedly turned the ventilator on, and the pressure was noted to spike during the first breath.The clinician reportedly removed the test lung and used his finger to block the patient wye.He reportedly pushed the flush valve, and the bellows did not move.The clinician reportedly pushed the flush valve two more times, and the bellows inflated to the top and the ventilator started cycling.The clinician reportedly reconnected the anesthesia machine to the patient, and the unit cycled as expected.The case continued with no further reported complaint.

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.

Manufacturer Narrative

Changed from serious injury to malfunction: the initial mdr indicated the event to be a serious injury due to medical intervention.However, the intervention performed by the clinician was precautionary and not necessary to prevent permanent impairment/damage.Following the case, the hospital reported that a slight pneumo-mediastinum was noted, and a chest tube was inserted as a precautionary measure.It is uncertain if the pneumo-mediastinum was a result of the nuss bar surgical procedure or the temporary pressure delivered by the ventilator.The hospital stated that a pneumo-mediastinum is not uncommon following a nuss bar procedure.It was reported that the patient recovered as expected and was discharged without extended stay.A ge healthcare service representative performed an equipment checkout and noted a 500 ml/min leak due to a cracked flow sensor.The hospital's reported complaint of high pressure was not duplicated.The reported leak from the cracked expiratory flow sensor did not contribute to the reported event.Ge healthcare subsequently requested the equipment be returned to the manufacturing facility for further investigation into root cause.Once received, a preoperative checkout was performed.During the checkout, the machine was switched from bag to vent mode, and the airway pressure increased without bellows movement.The bellows was fully collapsed and pressure continued to rise to 80 cmh2o until relieved by removing the patient circuit.This represents a failure to pass the preoperative checkout and was a duplication of the customer reported complaint.The failure was reproduced again, with an occluded patient circuit.Pressure increased past the airway pressure gauge maximum reading of 100 cmh2o.At approximately 120 cmh2o, an audible pop was heard, breathing system pressure relieved, and the bellows and machine began to react normally.The preoperative checkout was later repeated and passed.It was speculated that the bag valve poppet was stuck and did not open when the bag-to-vent selector was moved to the vent position.The build-up of pressure on the patient side of the circuit was eventually great enough to dislodge it, resulting in the pop heard and the ventilator cycling as expected.The root cause of the temporary unintended pressure was determined to be a transiently stuck bag mode valve poppet.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA 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 60010-3076 ; 8472774719
• MDR Report Key: 4338477
• MDR Text Key: 5177209
• Report Number: 2112667-2014-00123
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 51