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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fall (1848)
Event Date 12/23/2018
Event Type  Death  
Manufacturer Narrative
Date of report: 27feb2019.The third-party biomed evaluated the ventilator no malfunctions were found.The device passed all testing; however, the event logs didn't contain data on the date the incident reportedly occurred (b)(6) 2018.The customer indicated to the biomed they were not sure of the exact ventilator that was involved in the incident.The philips field service engineer (fse) evaluated the ventilator and it passed all testing.The fse also noted that the event logs did not contain data on the reported incident date and this was communicated to the customer.
 
Event Description
The customer reported that on (b)(6) 2018 a patient using a v60 ventilator fell out of bed and passed away.No additional patient detail has been provided by the customer even with repeated attempts to obtain the information.There is no allegation from the customer that the ventilator malfunctioned nor caused or contributed to the patient death.
 
Manufacturer Narrative
The risk manager at seton medical center, williamson, reported that based on their internal investigation there is no allegation that the ventilator involved in the reported incident malfunctioned nor caused or contributed to the patient death.The contact declined to reveal patient information including the details of the incident and cause of patient death due to patient privacy standards.The contact stated that the ventilator that was quarantined and evaluated by the third-party biomed and the philips field service engineer as part of the investigation may not have been the ventilator that was involved in the incident and the contact reportedly will perform an internal investigation on their process to quarantine a device in the case of adverse events.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8374574
MDR Text Key137295538
Report Number2031642-2019-01137
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public(01)00884838020054
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT MASK, CIRCUIT, HUMIDIFIER: UNKNOWN; PATIENT MASK, CIRCUIT, HUMIDIFIER: UNKNOWN
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