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

Device Problems Nonstandard Device (1420); Output above Specifications (1432)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2013

Event Type  malfunction  

Event Description

The hospital reported that, at start of case following manual ventilation, the clinician switched to pcv-vg mode.The ventilator provided larger than expected tidal volume.The clinician switched between manual mode and mechanical mode and tidal volume was as expected.The case was completed with no further reported complaint.There was no reported patient injury.

Manufacturer Narrative

Under european law, patient information is considered confidential and will not be released by the hospital.Per 21 cfr 806 ge healthcare initiated a medical device correction for this issue under report no.(b)(4).

• Brand Name: AISYS
• 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: 4900061
• MDR Text Key: 16904017
• Report Number: 2112667-2015-00050
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0009-2014
• Patient Sequence Number: 1