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

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The bag arm was reattached, and the unit was returned to service.

Event Description

The hospital reported that the bag arm had become detached from the unit, this would prevent the unit from manually ventilating.There was no report of patient involvement.

• Brand Name: AESTIVA 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: stephanie cass ; 3000 n. grandview boulevard; waukesha, WI 53188
• MDR Report Key: 5826369
• MDR Text Key: 50562799
• Report Number: 2112667-2016-01433
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/27/2016

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2001
• 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