MAUDE Adverse Event Report: GE DATEX-OHMEDA ANES GE DATEX-OHMEDA ANESTHESIA MACHINE ANESTHESIA CART MACHINE

Model Number MODEL AESTIVA 5

Device Problem Failure to Deliver (2338)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Vomiting (2144); Loss of consciousness (2418)

Event Date 10/10/2013

Event Type  Injury  

Event Description

Anesthesia machine quit working during anesthesia for cystoscopy and stent placement. Although we cannot know definitively it is suspected that the disruption in gas caused the patient to enter a semi-conscious state. Crna unable to ventilate patient as bag would not inflate on anesthesia machine. Patient began to bite down on airway and began to vomit. Patient aspirated vomitus and surgical case aborted. Patient able to undergo procedure the next day and was discharged home on antibiotics for aspiration pneumonia.

• Brand Name: GE DATEX-OHMEDA ANESTHESIA MACHINE
• Type of Device: ANESTHESIA CART MACHINE
• Manufacturer (Section D): GE DATEX-OHMEDA ANES; juputer FL 33468 7
• MDR Report Key: 3427180
• MDR Text Key: 3951933
• Report Number: MW5032357
• Device Sequence Number: 1
• Product Code: BSZ

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2013

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/21/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: MODEL AESTIVA 5
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 10/21/2013 Patient Sequence Number: 1

Treatment

ANESTHESIA