MAUDE Adverse Event Report: GE HEALTHCARE, INC. AISYS; GAS-MACHINE, ANESTHESIA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 05/09/2014

Event Type  No Answer Provided  

Event Description

Once the patient intubated, the positive end-expiratory pressure (peep) was measuring 10 cm.The anesthesia machine peep was set at 0cm(zero), with peep measuring 10 cm.The machine was then turned off, and the patient was ventilated by hand with an ambu bag with 100% oxygen.The lungs were determined to be clear but the patient's heart rate (svt) was 140bpm, they were also hypotensive.

• Brand Name: AISYS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE, INC.; 9900 w. innovation drive,; rp2138; wauwatosa, WI 53226
• MDR Report Key: 3852965
• MDR Text Key: 4659877
• Report Number: 3852965
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2014

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?: *
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR