MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ALADIN; ANESTHESIA GAS MACHINE

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2017

Event Type  malfunction  

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.No report of patient involvement.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the unit fails the vaporizer output efficacy test.There was no report of patient involvement.

Manufacturer Narrative

Product engineering reviewed this complaint and advised that the model number ¿a-vdes-00-en-1¿ denotes that this is a desflurane cassette.Per the desflurane accuracy specification in the technical reference manual, +/-20% accuracy is specified and thus allowed range for desflurane is 4.0% - 6.0% with concentration setting at 5.0 %.Per the complaint data, with dial set at 5%, unit was measuring 5.7 % which is in specification.Because there was no malfunction, this event was not reportable.

• Brand Name: ALADIN
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki ; FI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7074751
• MDR Text Key: 94096671
• Report Number: 9610105-2017-00069
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1