MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CS650; ANESTHESIA GAS MACHINE

Model Number 1012-9650-000

Device Problems Sticking (1597); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

Changed the position of flow sensors, and calibrated them to fix the reported issue.(b)(4).

Event Description

The hospital reported that, during patient use, the bellows are stuck and ventilator stopped.The customer had to manually ventilate the patient.There was no reported patient injury.

Manufacturer Narrative

Additional information was received that the information in the initial mdr was in error.The unit continued to ventilate and the unit alarmed due to flow sensor issue.The initial mdr was not reportable.

• Brand Name: CS650
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6674490
• MDR Text Key: 78614928
• Report Number: 2112667-2017-01197
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-9650-000
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• 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