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

Model Number V60

Device Problems Grounding Malfunction (1271); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21may2020.

Event Description

The customer reported higher blower temperature.There was patient involvement, but no one was harmed.The manufacturer¿s field service engineer (fse) could not duplicate the reported higher blower temperature issue, but verified the error of high blower temperature in the history.The fse ran the unit for half hour in normal mode, and no problem was found.All connections and tubing were secure.The fse replaced the blower assembly, and the motor controller as a preventative measure to address the reported problem.During failure investigation, the ground resistance test failed, so the power cord was replaced.The unit passed the required test of the performance verification successfully.

Manufacturer Narrative

G4: 09oct2020.B4: 13oct2020.The blower motor assembly was received for evaluation.Visual inspection of the blower assembly revealed no anomalies.A failure investigation (fi) technician installed blower motor into a fi ventilator to duplicate the reported issue.The fi ventilator was booted up unit in normal operation mode and checked for alarms and errors.The returned blower motor passed all testing, and the reported complaint was not verified and could not be confirmed.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.

• 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: 10080408
• MDR Text Key: 191980334
• Report Number: 2031642-2020-01801
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER