PULMONARY/METABOLIC SYSTEM (VMAX SERIES) VMAX 299 769200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1996-12-06 for PULMONARY/METABOLIC SYSTEM (VMAX SERIES) VMAX 299 769200 manufactured by Sensormedics Corp..

Event Text Entries

[38871] While testing a pt on the vmax299, smoke was observed coming out of the back right corner of the analyzer module. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2050001-1996-00042
MDR Report Key56516
Report Source05,06,07
Date Received1996-12-06
Date of Report1996-12-06
Date of Event1996-11-14
Date Mfgr Received1996-11-14
Device Manufacturer Date1995-09-01
Date Added to Maude1996-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePULMONARY/METABOLIC SYSTEM (VMAX SERIES)
Generic NamePULMONARY/METABOLIC TESTER
Product CodeBZC
Date Received1996-12-06
Returned To Mfg1996-11-22
Model NumberVMAX 299
Catalog Number769200
Lot NumberNA
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key57036
ManufacturerSENSORMEDICS CORP.
Manufacturer Address22705 SAVI RANCH PARKWAY YORBA LINDA CA 928874645 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-12-06

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