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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ANESTHESIA CARE A/S INTLLISAVE AX700 ANESTHESIA SYSTEM
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PHILIPS ANESTHESIA CARE A/S INTLLISAVE AX700 ANESTHESIA SYSTEM Back to Search Results
Model Number 866205
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2014
Event Type  Injury  
Event Description
The user reported that the display froze during clinical use.The attending clinicians followed the set clinical protocols using alternative source of oxygen and ventilation.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
The manufacturer¿s contact person address is (b)(4).
 
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Brand Name
INTLLISAVE 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 Key4356331
MDR Text Key5118202
Report Number3010587095-2014-00015
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K122063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number866205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received11/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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