V60 VENTILATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for V60 VENTILATOR manufactured by Respironics California, Inc.

Event Text Entries

[187683026] Date of event: (b)(6) 2020. Date of report: 03/23/2020.
Patient Sequence No: 1, Text Type: N, H10


[187683027] It was reported that while in use, the ventilator shut down and restarted. The patient was removed from the ventilator and placed on an alternate ventilator. The patient was not harmed or injured as a result of the reported event. The service engineer (se) inspected the device. The se could not duplicate the reported issue, but did find in the ventilator diagnostic logs an error code indicating a ventilator restart had occurred on (b)(6) 2020 11:51 am. Review of the ventilator diagnostic codes found an error code indicating low inspiratory pressure, proximal pressure line disconnect, oxygen not available, low tidal volume, patient disconnect. The se replaced the central processing unit (cpu) board to address the reported issue. The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031642-2020-00999
MDR Report Key9868323
Report SourceUSER FACILITY
Date Received2020-03-23
Date of Report2020-03-11
Date of Event2020-03-05
Date Mfgr Received2020-03-11
Device Manufacturer Date2011-11-21
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. MELISSA ABBOTT
Manufacturer Street2271 COSMOS COURT
Manufacturer CityCARLSBAD CA 92011
Manufacturer CountryUS
Manufacturer Postal92011
Manufacturer Phone9093746996
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameV60 VENTILATOR
Generic NameVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Product CodeMNT
Date Received2020-03-23
Model NumberV60
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS CALIFORNIA, INC
Manufacturer Address2271 COSMOS COURT CARLSBAD CA 92011 US 92011


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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