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

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.(b)(6).

Event Description

The hospital reported that, when ac power was lost during a case, the unit did not switch to battery backup.There was no reported patient injury.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The batteries were replaced, and the unit was returned to service.Based on the date code of the batteries, the charge date was january 2007.Per the aisys technical reference manual, batteries are to be replaced every 4 years, however, batteries that pass the capacity test can be considered viable for battery backup of the system for up to 6 years at the discretion of the hospital.The batteries in this case were 8 years old and past the recommended or extended replacement period.

• Brand Name: AISYS
• 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 56718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076
• MDR Report Key: 5111256
• MDR Text Key: 27060626
• Report Number: 2112667-2015-00162
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2015
• 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