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

Model Number V60

Device Problems No Display/Image (1183); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 14aug2020.

Event Description

The customer (biomed) contacted philips stating that the respiratory therapist reported that the unit went vent inoperative and had a black screen while in use.The device was being used on a patient at the time of the event.The respiratory therapist stated that they swapped out the ventilator and there was no patient impact as a result of this event.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The caller stated the 1009 error was noted in the significant event logs.The rse advised the caller per the service manual to verify proximal pressure and machine tubing connections and to verify the pressures and flows.The part number for a replacement data acquisition board was also provided to the customer.

Manufacturer Narrative

G4: 24aug2020 b4: 25aug2020 the customer replied on (b)(6) 2020 that in addition to the machine pressure sensor autozero error, alarm message: high o2 supply pressure was also in the event logs.The customer stated that the data acquisition (da pcba) board was replaced, and the device returned to full functionality.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: 14oct2020 b4: (b)(6) 2020 the data acquisition assembly (assy,pcb,data acq, v8000) was received for evaluation.Visual inspection revealed no anomalies.A failure investigation (fi) technician installed the daq pcba board into a fi ventilator to attempt to duplicate the reported issue.The daq pcba was booted into the normal ventilation mode and the fi technician could not duplicate the reported issue.The customer complaint was not verified.No fault was found with the returned daq pcba.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: 10411593
• MDR Text Key: 203643628
• Report Number: 2031642-2020-02785
• 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,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 07/23/2020
• Supplement Dates FDA Received: 08/25/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER