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

Model Number V60

Device Problem Unable to Obtain Readings (1516)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The customer reported the tidal volume could not be read.The ventilator was on a patient.The patient was swapped to a different ventilator.There was no harm.The customer reports the tidal volume was set for 435 and only delivering 3-4ml.The remote service engineer (rse) advised customer to set zero pressure and flow and to observe the average air and average o2 readings.The customer found the following results: air (2.3) and o2(0.0).The rse advised to suspect that the customer has a defective flow sensor.The customer reports that the back light is flickering as well.The rse suggest possible replacement of the lcd or the user interface pcba.An authorized service provider (asp) evaluated the ventilator and could not find any error codes.The asp performed all tests associated with pressure, leak, pressure accuracy, flow accuracy, air/o2 mix accuracy.Unit failed on 30% o2.Asp plans to replace the gas delivery system (gds) and retest all pressure, leak, flow, and mix accuracy.Further information is pending.

Manufacturer Narrative

The authorized service provider replaced the gas delivery system, and the issue was resolved.

Manufacturer Narrative

The gas delivery subsystem (gds) was returned to philips for failure investigation (fi).The customer complaint was verified.The root cause was failure of the airflow sensor, caused by u1 drifting out of calibration.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12913562
• MDR Text Key: 281588122
• Report Number: 2031642-2021-05662
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 11/30/2021; 11/23/2022
• Supplement Dates FDA Received: 12/22/2021; 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1