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

Device Problems False Device Output (1226); Moisture or Humidity Problem (2986)

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

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury.Reference mdr 2112667-2013-00005.A ge healthcare service representative performed a checkout of the equipment and noted that the flow sensor diaphragm was stuck to the top of the flow sensor housing.Manual mode of ventilation is available to maintain ventilation of the patient.Flow sensors of this type are customer replaceable, are recommended for replacement after 3 months, and are warranted for 6 months.The maintenance schedule in the user reference manual states: "replace the disposable flow sensor (plastic).Under typical use, the sensor meets specifications for a minimum of 3 months." in engineering evaluation, the stuck diaphram has been able to be reproduced by: (1) a hard impact, such as dropping the flow sensor, or by (2) sticking an object into the flow sensor, causing the diaphragm to stick open.If a sensor is subjected to a hard impact, it is still unlikely that the diaphragm will get stuck in the open position.

Event Description

The hospital reported that the unit indicates apnea, does not measure volume, and excessive moisture is noted in the patient circuit.There was no reported patient injury.

• Brand Name: AESPIRE 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): 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: 5008724
• MDR Text Key: 24154599
• Report Number: 2112667-2015-00107
• 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
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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