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 06 report with the FDA on 1997-05-14 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..

Event Text Entries

[54991] Device was being tested prior to use on a patient after being in storage for an undetermined amount of time. Testing by the facility indicated that servicing was required on the device because of "no low alarm control, and a missing ring from the switch. " device was returned for servicing. During servicing, it was determined that the alarm was not functional. Device was not on a patient at the time of the reported problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-1997-00008
MDR Report Key91070
Report Source06
Date Received1997-05-14
Date of Report1997-05-13
Date of Event1997-04-14
Report Date1997-05-14
Device Manufacturer Date1992-06-01
Date Added to Maude1997-05-16
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 Received1997-05-14
Returned To Mfg1997-04-11
Model Number332259
Catalog Number332259
Lot NumberNA
ID Number26924-1
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age5 YR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key89974
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 1997-05-14

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