MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA MACHINE

Device Problem Inadequate Lighting (2957)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 10/18/2017

Event Type  Injury  

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.Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

The hospital reported a patient reported having awareness of the surgical procedure.It was further reported that, as a result of the awareness, the patient received psychiatric treatment.There is no allegation of equipment malfunction; the equipment remains in use.

Manufacturer Narrative

When asked if the hospital wanted a checkout of the equipment by ge healthare, the hospital denied the request, indicating the reported event was not due to an equipment malfunction.The hospital further stated the case anesthesiologist accepted responsibility for the reported event, however, further information about the anesthesiologist¿s actions which may have led to the patient awareness was not provided to gehc.The aisys cs2 continued to be used in subsequent cases with no reported complaint.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7185452
• MDR Text Key: 97069136
• Report Number: 2112667-2018-00112
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/11/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 68