AIRWAY PRESSURE MONITOR 332259

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-11-07 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..

Event Text Entries

[72415] Customer reported that the alarm was not sounding. Customer indicated that the device was being used on a patient at the time of the alleged problem, and that there was no harm to the patient. No additional patient information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-1997-00024
MDR Report Key131053
Report Source08
Date Received1997-11-07
Date of Report1997-11-07
Date of Event1997-10-08
Date Reported to Mfgr1997-10-08
Date Mfgr Received1997-10-08
Device Manufacturer Date1994-12-01
Date Added to Maude1997-11-13
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
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRWAY PRESSURE MONITOR
Generic NameAIRWAY PRESSURE MONITOR
Product CodeCAP
Date Received1997-11-07
Returned To Mfg1997-10-13
Model Number332259
Catalog Number332259
Lot NumberNA
ID Number41956
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key128113
ManufacturerRESPIRONICS, INC.
Manufacturer Address1001 MURRY RIDGE DR. MURRYSVILLE PA 156688550 US
Baseline Brand NameAIRWAY PRESSURE MONITOR
Baseline Generic NameMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
Baseline Model No332259
Baseline Catalog No332259
Baseline IDNA
Baseline Device FamilyMONITORS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK902276
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1997-11-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.