V60 VENTILATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-18 for V60 VENTILATOR manufactured by Respironics California, Inc.

Event Text Entries

[186610395] Date of event: (b)(6) 2020. Date of report: 18mar2020.
Patient Sequence No: 1, Text Type: N, H10


[186610396] It was reported that the unit had a touchscreen failure resulting in the touch response inaccuracy. The device was being placed into use on a patient whose condition had deteriorated. The unit was started, pressure adjusted and was connected to the patient when the touchscreen stopped functioning. There was no additional patient harm reported as a result of this; as the patient was transferred to another unit. However, the patient was said to previously be in poor condition and there was a delay in therapy. The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue. The fse replaced the touchscreen and user interface (ui) to power management (pm) printed circuit board assembly (pcba) cable and the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031642-2020-00955
MDR Report Key9848553
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-18
Date of Report2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2012-05-03
Date Added to Maude2020-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2020-03-18
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 2020-03-18

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