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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS NOVAMETRIX, LLC CAPNOSTAT C5 ANALYZER, GAS, CARBONDIOXIDE, GASEOUS-PHASE

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RESPIRONICS NOVAMETRIX, LLC CAPNOSTAT C5 ANALYZER, GAS, CARBONDIOXIDE, GASEOUS-PHASE Back to Search Results
Device Problem Temperature Problem (3022)
Patient Problem Burn, Thermal (2530)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once he investigation is complete.
 
Event Description
The customer ((b)(6)) states that their end user customer ((b)(6) hospital) was monitoring an anesthetic surgery and the mainstream module became very hot ,very quickly and the veterinary nurse was "scalded" while taking the unit down. The sensor was being used with an edan m3 patient monitor. Follow up with the customer found that the veterinary hospital employee "was not badly hurt and did not require further treatment for the injury. ".
 
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Brand NameCAPNOSTAT C5
Type of DeviceANALYZER, GAS, CARBONDIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
RESPIRONICS NOVAMETRIX, LLC
5 technology drive
wallingford CT 06492
Manufacturer Contact
stacey durand
5 technology drive
wallingford, CT 06492
MDR Report Key6721189
MDR Text Key80427496
Report Number1219324-2017-00001
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K042601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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