MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The water was drained from the bag hose to clear the reported problem.The unit was returned to service.The customer contact reports there is no patient information available.

Event Description

The hospital reported the unit was over delivering pressure.There was no report of patient injury.

• Brand Name: AESPIRE 7100
• 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: 7767827
• MDR Text Key: 116600088
• Report Number: 2112667-2018-01571
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000706
• 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: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• 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: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2004
• 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