CARE FUSION MO11766889ON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-14 for CARE FUSION MO11766889ON manufactured by Care Fusion Respiratory Patient Care.

Event Text Entries

[16224103] Hfov pediatric oscillator failed while in use on the pt. Stopped running. The pt's bp dropped. The pt was manually bagged, dopamine drip was increased and epi drip started. A ns bolus was given. A replacement machine was obtained and started on the pt without incident. The following info was obtained in our investigation: the mushroom caps/valves that we have currently are all from various lot numbers. I have inspected several different packages and i am unable to detect from the naked eye any differences between any of them, they all look the same to me. We did order additional supplies and they were overnighted and should be here tomorrow. The rt who spoke directly to technical support. The call went out (b)(6) about 9. They went through a series of trouble shooting checks; the last thing they tried was to apply external pressure to the mushroom cap to see if that was where the leak was possibly at. (b)(6) stated that with pressure on the cap, the pressure within the oscillator did come up. (b)(6) then replaced the caps and the oscillator; subsequently the oscillator operated normally. Technical support did indicate to her, (b)(6), that there had been some issues with the mushroom caps recently, but did not elaborate on specifics. At the time of the call, (b)(6)'s intent was to trouble shoot the machine and get the pt placed on it. She did not inquire as to specific lot numbers of the caps; however, did inquire about recall issues when she was told that the issues didn't meet fda requirements for recall.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029427
MDR Report Key3015754
Date Received2013-03-14
Date of Report2013-03-14
Date of Event2013-03-04
Date Added to Maude2013-03-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCARE FUSION
Generic NameMUSHROOM CAP/VALVE DIAPHRAGM SET
Product CodeBYW
Date Received2013-03-14
Catalog NumberMO11766889ON
Lot NumberNOT AVAILABLE
ID NumberREF #
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCARE FUSION RESPIRATORY PATIENT CARE
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-03-14

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