PRECISION PM1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-04 for PRECISION PM1000 manufactured by Precison Medical.

Event Text Entries

[4819228] Patient on o2 via oxygen flow meter. The oxygen flow selector was turned to the wrong port, off instead of on. Rt assisting patient found patient desat at 85%. Rt adjusted oxygen flow selector to the correct port and o2 stat went up to 97%.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037655
MDR Report Key3986980
Date Received2014-08-04
Date of Report2014-08-01
Date of Event2014-07-02
Date Added to Maude2014-08-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRECISION
Generic NameFLOW SELECTOR
Product CodeCAX
Date Received2014-08-04
Model NumberPM1000
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerPRECISON MEDICAL
Manufacturer AddressNORTHHAMPTON 18067 18067


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-04

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