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

Model Number V60

Device Problem Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.11mar2021.

Event Description

The customer called into technical support (ts) reporting that the device is displaying a 1122 (blower temp high) error code.The device was in clinical use at the time the reported issue was discovered, however, there was no harm to the patient or user.

Manufacturer Narrative

The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.It was determined that the filters are clean and the fan is functioning.The rse advised the caller that the unit may have a faulty blower or mc pcb.The rse advised the caller that the unit may have a faulty blower or mc pcb.The biomed customer found that it was the type of filter that the customer was using on cpap mode.After further troubleshooting, it was traced to a type of filter being used that caused the reported issue, user error.Per good effort response, it was confirmed that this was not device-related and that it was due to the type of filter that was being used on cpap mode that caused the reported issue.It was found to be a user error that caused the reported problem.There was no malfunction with the device itself.The device passed the required performance verification tests per philips standards.

• 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: 11465834
• MDR Text Key: 240987794
• Report Number: 2031642-2021-00926
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2012
• 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