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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 Problems Defective Alarm (1014); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Respiratory Distress (2045)
Event Date 07/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).The device was in patient use when the reported event occurred and the patients spo2 dropped and then recovered after the unit was restarted.Device testing was performed by the service technician and no abnormality was found.
 
Event Description
The customer reported that while in patient use the v60 ventilator stopped operating without an alarm.The technician reviewed the event log and no error was recorded.
 
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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
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
lisa cardenas
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7738879
MDR Text Key115675548
Report Number2031642-2018-01525
Device Sequence Number0
Product Code MNT
Reporter Country CodeJA
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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