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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ANESTHESIA CARE BSZ; DAMECA, GAS-MACHINE, ANESTHESIA
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PHILIPS ANESTHESIA CARE BSZ; DAMECA, GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number 866205
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The users reported that the knob for the flowmeter fell off.The local field service engineer determined that the knob that fell off was for the auxiliary o2 rotameter.This auxiliary o2 rotameter is not part of either automated or manual ventilation delivery.If the knob fell off, the device user may not be able to change the setting on this auxiliary o2 rotameter.Philips has not been able to rule out that this could be a health risk if it recurred.
 
Manufacturer Narrative
(b)(4).A follow up report will be submitted upon completion of the investigation.
 
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Brand Name
BSZ
Type of Device
DAMECA, GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
PHILIPS ANESTHESIA CARE
islevdalvej 211
roedovre; region hovestaden 2610
DA  2610
Manufacturer Contact
phyllis mccarthy
3000 minuteman road
andover, MA 01810
9786592811
MDR Report Key3814910
MDR Text Key4479610
Report Number3010587095-2014-00009
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K122063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2014
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 Health Professional
Device Model Number866205
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/09/2013
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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