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

Model Number 866205

Device Problems Device Inoperable (1663); Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  Injury  

Event Description

The user reported that during surgery, the anesthesia system controls froze when the touchscreen was touched.The attending clinician tried to increase the flow of oxygen but all touch screen controls were inoperative and there was no way of changing ventilation parameters.The attending clinician took the action of manual delivery of ventilation and anesthesia.No adverse impact to the patient was reported.

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

(b)(4).

• Brand Name: INTELLISAVE AX700 ANESTHESIA SYSTEM
• Manufacturer (Section D): PHILIPS ANESTHESIA CARE A/S; islevdalvej 211; roedovre 2610 ; DA 2610
• Manufacturer Contact: phyllis mccarthy ; 3000 minuteman road; andover, MA 01810 ; 9786592811
• MDR Report Key: 4356329
• MDR Text Key: 5222471
• Report Number: 3010587095-2014-00016
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K122063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Required Intervention