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

Model Number V60 PLUS

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of this report: 18feb2021.

Event Description

The customer called into technical support (ts) reporting that the device displayed a blower temperature high error.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the pcba, motor control and the blower assembly to resolve the reported issue.The unit passed required performance verification tests per philips standards and was put back into service.

Manufacturer Narrative

The motor controller(mc) pcba was received for failure investigation.Visual inspection of the motor controller (mc) pcba revealed no evidence of damage or contamination.The blower assembly and motor controller (mc) pcba passed all testing.A high blower temperature alarm (error code) could not be duplicated.There were no faults found with the returned blower assembly and motor controller (mc) pcba.

Manufacturer Narrative

The motor controller(mc) pcba and blower assembly were received for failure investigation.Visual inspection of the motor controller (mc) pcba revealed no evidence of damage or contamination.The blower assembly and motor controller (mc) pcba passed all testing.A high blower temperature alarm (1122 error code) could not be duplicated.There were no faults found with the returned blower assembly and motor controller (mc) pcba.

Manufacturer Narrative

The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.It was confirmed by rt that the device was swapped out for another.There was no medical intervention nor delay in therapy noted.

• 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
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11343475
• MDR Text Key: 233799937
• Report Number: 2031642-2021-00643
• Device Sequence Number: 1
• Product Code: MNT
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER