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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Disconnection (1171)

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

Event Date 08/03/2021

Event Type  malfunction  

Event Description

The customer reported "patient disconnect" alarm occurred.The field service engineer (fse) could not duplicate the issue.The service engineer (se) that visited onsite confirmed that when a circuit was removed, then the reported alarm sounded and diagonal line(s) indicating that the alarm was resolved quickly.However, the high-level alarm remained sounding.The field service engineer (fse) re-ran the unit under performance verification testing (pvt) and no anomaly was found.The unit was returned to service.The device was not in use on a patient.No patient or user harm was reported.

• 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
• MDR Report Key: 12408564
• MDR Text Key: 269583192
• Report Number: 2031642-2021-04775
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

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: No Information
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/03/2021
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 09/01/2021
• Date Device Manufactured: 08/16/2017
• 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