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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 15sep2020.

Event Description

The customer reported that the unit have an "error" message during use on patient.Found during service.On/off overlay flickering green light emitting diode (led) when pressed and unit failed flow accuracy test for oxygen mix accuracy.The customer reported that the unit was in use on patient , but there was no patient harm reported.The field service engineer (fse) found during service, on/off overlay flickering green led when pressed.Flow accuracy did not pass specification for oxygen mix accuracy.

Manufacturer Narrative

G4:08oct2020, b4:07dec2020.The customer reported that the unit has an error message during use on a patient.Found during service on/off overlay flickering green led when pressed and unit failed flow accuracy test for oxygen mix accuracy.The field service engineer confirmed the issue.The field service engineer (fse) confirmed the unit would not power on.A review of the diagnostic report (drpt) found 35 volt failure errors.The fse replaced the power management (pm) board to address the 35v failure, power switch overlay to address the flickering overlay issue, flow sensor and gas delivery system to address flow accuracy failure.After replacing all the parts, the (fse) was able to power on the unit.The (drpt) was review again, and the errors have not reappeared.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.

Event Description

The customer reported that the unit have an "error" message during use on patient.Found during service.On/off overlay flickering green light emitting diode (led) when pressed and unit failed flow accuracy test for oxygen mix accuracy.The customer reported that the unit was in use on patient , but there was no patient harm reported.The field service engineer (fse) found during service, on/off overlay flickering green led when pressed.Flow accuracy did not pass specification for oxygen mix accuracy.

• 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 Key: 10538425
• MDR Text Key: 208168983
• Report Number: 2031642-2020-03294
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER