MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650 A1; ANESTHESIA GAS MACHINE

Device Problem Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a n2o mixer hardware failure during system checkout.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received stating that this failure would not allow a hypoxic delivery to the patient.This was not a reportable malfunction.Additional information was received stating that this failure would not allow a hypoxic delivery to the patient.This was not a reportable malfunction.

• Brand Name: CARESTATION 650 A1
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7956384
• MDR Text Key: 123396711
• Report Number: 2112667-2018-02005
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 11/05/2018
• 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