MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 620; ANESTHESIA GAS MACHINE

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2022

Event Type  malfunction  

Event Description

It was reported that there was a malfunction resulting in loss of mechanical ventilation.There was no patient involvement.

Manufacturer Narrative

Ge healthcares 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.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The power management board was ordered for replacement to resolve the issue.

• Brand Name: CARESTATION 620
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 15614594
• MDR Text Key: 301850945
• Report Number: 2112667-2022-04168
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1