MAUDE Adverse Event Report: DATEX-OHMEDA, INC AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problems Device Alarm System (1012); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 05/21/2015

Event Type  malfunction  

Event Description

The hospital reported that, during a case, the anesthesia machine went into standby mode without an alarm.The clinician reportedly cycled power, and the case was able to be continued.There was no reported patient injury.

Manufacturer Narrative

Under european law, patient information is considered confidential and will not be released by the hospital.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

A ge healthcare service representative performed a checkout of the equipment.The equipment was checked, and the reported complaint was confirmed.The on/standby switch assembly was replaced and the unit was returned to service.The switch was not returned for investigation.An exact root cause of the reported complaint cannot be determined without a sample.

• Brand Name: AESPIRE 7100
• 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 60010-3076 ; 8472774719
• MDR Report Key: 4903215
• MDR Text Key: 6069730
• Report Number: 2112667-2015-00024
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• 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: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2007
• 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