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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Low Oxygen Saturation (2477)
Event Date 07/08/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of event: (b)(6) 2020.
 
Event Description
A user facility stated via a medwatch 3500a report, that a respironics v60 ventilator stalled while providing bipap therapy to a patient and the patient experienced an event of oxygen desaturation.The device was in use on a patient at the time of the reported device behavior and the patient experienced an event of oxygen desaturation.
 
Manufacturer Narrative
G4: 10nov2020.B4: 10nov2020.H1: h6: patient code: updated to death.This patient with a height of 145 centimeters (cm), was admitted to a hospital on (b)(6) 2020, with an admitting diagnosis of fever and chills.On (b)(6) 2020, the patient experienced an outcome of death, with the primary and secondary cause not reported.It is unknown if the patient was receiving ventilation therapy via the v60 ventilator at the time of the reported outcome.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.
 
Manufacturer Narrative
G4: 03nov2020.B4: (b)(6) 2020.The hospital's biomedical engineer evaluated the device and was unable to duplicate the symptom.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.Philips is unable to confirm the customer¿s allegation since there was no technical support requested.No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.This user facility reported via medwatch 3500a report number (b)(4), that a female patient born (b)(6) 1939, weighing 70.6 kilograms, with height not reported, was admitted to the hospital on a date not reported, with an admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed bilevel positive airway pressure (bipap) therapy via the respironics v60 ventilator; device settings, configuration, and patient circuit brand, model, lot number, and expiration date not reported.While admitted on (b)(6) 2020, the ventilator generated a visual alarm of ¿blower stalled¿ and the touch screen ¿was not responding to commands¿, the device was not ventilating the patient in bipap mode, the patient experienced an event of peripheral capillary oxygen saturation (spo2) in the 50s, hospital staff removed the bipap device from the patient, and administered 100% oxygen via a nonrebreather mask; brand, model, lot number, and expiration date not reported.The patient event of oxygen desaturation resolved within 20 to 30 minutes of medical intervention, with spo2 in the 90s.As of (b)(6) 2020, the patient remains admitted in an intermediate medical care unit receiving bipap therapy.No relevant laboratory data was reported.There is no information to support that a malfunction occurred.Philips was unable to determine the cause of the reported symptom as it could not be reproduced.No parts were returned for failure investigation.Therefore, the root cause at the component level could not be determined.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.
 
Manufacturer Narrative
Further information received has determined that the patient expiration was not related the alleged device malfunction, nor as cause or contribution to the patient outcome been found.The previous status of fda mdr - death is thereby being redacted and downgraded to serious injury due patient decrease in saturation of peripheral oxygenation and subsequent provision of medical intervention via a non-rebreather mask.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key10323339
MDR Text Key200379327
Report Number2031642-2020-02482
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received07/24/2020
Supplement Dates Manufacturer Received07/15/2020
07/15/2020
06/23/2021
Supplement Dates FDA Received11/04/2020
11/10/2020
06/23/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CRICUIT, MASK, AND HUMIDIFIER
Patient Outcome(s) Death; Required Intervention;
Patient Age81 YR
Patient Weight70
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