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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Unique identifier: (b)(4).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.The distributor performed a checkout of the equipment and confirmed the reported complaint.The defective flow sensor was replaced to resolve the reported issue.The distributor performed a checkout of the equipment and confirmed the reported complaint.The defective flow sensor was replaced to resolve the reported issue.

Event Description

The hospital reported a flow sensor failure with the diaphragm stuck in the open position.There was no report of patient involvement.

• Brand Name: AVANCE CS2
• 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: 10700700
• MDR Text Key: 214534297
• Report Number: 2112667-2020-02902
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 10/19/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Date Device Manufactured: 08/16/2016
• 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