* PR 02575

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 1997-10-17 for * PR 02575 manufactured by Bird Products Corp..

Event Text Entries

[101234] Mri vent tested on test lung and found to be operating within correct parameters. Placed on pt and pt seized, developed subcutaneous air in neck and chest. Physician felt pt had a possible air embolus. Chest x-ray revealed pneumothorax.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2021710-1997-00019
MDR Report Key128327
Report Source06
Date Received1997-10-17
Date of Report1997-08-06
Date of Event1997-07-14
Date Facility Aware1997-07-14
Report Date1997-08-06
Date Reported to FDA1997-08-06
Date Reported to Mfgr1997-08-25
Date Mfgr Received1997-09-17
Date Added to Maude1997-10-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameEXHALATION VALVE FOR CIRCUIT
Product CodeCBP
Date Received1997-10-17
Returned To Mfg1997-08-11
Model NumberPR 02575
Catalog NumberPR 02575
Lot NumberNA
ID Number510K PREAMEND
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key118380
ManufacturerBIRD PRODUCTS CORP.
Manufacturer Address1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US
Baseline Brand Name*
Baseline Generic NameEXHALATION VALVE FOR CIRCUIT
Baseline Model NoPR 02575
Baseline Catalog NoPR 02575
Baseline ID510K PREAMEND

Patients

Patient NumberTreatmentOutcomeDate
101. Death 1997-10-17
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