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

Model Number 866205

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The user reported that the device gave a "system error" on the display during self test.There was no patient involvement.

Manufacturer Narrative

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

• Brand Name: INTELLISAVE AX700 ANESTHESIA SYSTEM
• Manufacturer (Section D): PHILIPS ANESTHESIA CARE A/S; islevdalvej 211; roedovre ; DA
• Manufacturer Contact: phyllis mccarthy ; 3000 minuteman road; andover, MA 01810 ; 9786592811
• MDR Report Key: 4390292
• MDR Text Key: 5120978
• Report Number: 3010587095-2014-00018
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 12/03/2014

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: Other
• Device Model Number: 866205
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• 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