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

Model Number V60

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20jan2021.

Event Description

A machine fault was reported.There was no patient involvement.

Manufacturer Narrative

Air inlet filter obstruction was reported.The device was not being used for treatment when the reported event occurred.The alleged malfunction was confirmed by an authorized service personnel.The air inlet filter was replaced.The equipment worked normally after replacement.

• 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: 11205952
• MDR Text Key: 228882747
• Report Number: 2031642-2021-00255
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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