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

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A ge healthcare service representative performed a checkout of the equipment and reviewed the logs.The equipment was found to function within manufacturer's specifications.The unit was returned to service.

Event Description

The hospital reported that, during a case, the screen froze and alarmed for a system malfunction.The clinician reportedly cycled power and resolved the reported complaint.There was no reported patient injury.

• 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 53718
• Manufacturer Contact: stephanie cass ; 3000 n. grandview boulevard; waukesha, WI 53188-1696
• MDR Report Key: 5320001
• MDR Text Key: 34161578
• Report Number: 2112667-2015-00448
• 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: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2011
• 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