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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to ge healthcare.No repair information available.No patient information available after calls to customer 08/28/20, 09/01/20, and 09/02/20.

Event Description

The hospital reported a case of light anesthesia.The agent delivery was increased.The sevo cassette was removed and replaced with a desflurane cassette.Case was resumed.There was no report of patient injury.

• Brand Name: ALADIN II
• 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: 10487830
• MDR Text Key: 208343284
• Report Number: 2112667-2020-02511
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2007
• 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