MAUDE Adverse Event Report: PHILIPS ANESTHESIA CARE A/S INTELLISAVE AX700 ANESTHESIA SYSTEM

Model Number 866205

Device Problems Device Displays Incorrect Message (2591); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The user reported that the alarm "sample flow rate error on gas module" appeared during clinical use.The issue was intermittent.The attending clinician restarted the multigas module and the alarm disappeared.The device continued to work as specified and expected until the end of surgery.The "sample flow rate error on gas module" is activated when the multigas module measures a sample flow that is too high or too low and will typically be due to an occlusion in the sample tube or the water trap.The patient was not harmed.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The customer's biomed evaluated the device.

• Brand Name: INTELLISAVE AX700 ANESTHESIA SYSTEM
• Type of Device: ANESTHESIA SYSTEM
• Manufacturer (Section D): PHILIPS ANESTHESIA CARE A/S; islevdalvej 211; region hovedstaden; roedovre 2610 ; DA 2610
• Manufacturer Contact: phyllis mccarthy ; islevdalvej 211; region hovedstaden; roedovre 2610 ; DA 2610
• MDR Report Key: 4667095
• MDR Text Key: 5619149
• Report Number: 3010587095-2015-00005
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

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
• Device Model Number: 866205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1