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

Device Problems Electrical /Electronic Property Problem (1198); Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

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.Date of device manufacture year is 2007.The month of manufacture was unavailable at time of mdr filing.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The display power supply cord and 2 fuses were replaced.The unit was returned to service.

Event Description

The hospital reported that an electrical arc that occurred below the display caused the unit to shutdown unexpectedly during a case.The unit was swapped out to complete the case.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 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: 5717510
• MDR Text Key: 47207976
• Report Number: 2112667-2016-01107
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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: 05/11/2016
• 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