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 Calibration Problem (2890)

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

Event Date 01/13/2022

Event Type  malfunction  

Event Description

A proximal pressure sensor calibration data error alarm was reported to have occurred while the device was in use on a patient.A manufacturer sales representative confirmed the log of "proximal pressure sensor calibration data error" alarm the day following the date of occurrence.The ventilator was on a patient wearing a performatrak full face mask and due to the alarm, the hospital replaced the device with another v60 ventilator.The international service engineer evaluated the ventilator.The reported phenomenon was not duplicated despite run testing.The event log revealed that "check vent: proximal pressure sensor range error" (diagnosis code 110d) had occurred.The device was inspected but no anomaly was observed.The software was confirmed to be version 2.30.Overall checking, cleaning, run testing, and functional testing were performed on the device.

Manufacturer Narrative

Reporter phone number - (b)(6).

Manufacturer Narrative

(b)(6).

Event Description

A proximal pressure sensor calibration data error alarm was reported to have occurred while the device was in use on a patient.A manufacturer sales representative confirmed the log of "proximal pressure sensor calibration data error" alarm the day following the date of occurrence.The ventilator was on a patient wearing a performatrak full face mask and due to the alarm, the hospital replaced the device with another v60 ventilator.The international service engineer evaluated the ventilator.The reported phenomenon was not duplicated despite run testing.The event log revealed that "check vent: proximal pressure sensor range error" (diagnosis code 110d) had occurred.The device was inspected but no anomaly was observed.The software was confirmed to be version 2.30.Overall checking, cleaning, run testing, and functional testing were performed on the device.

• 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: 13446986
• MDR Text Key: 285154900
• Report Number: 2031642-2022-00361
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• 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

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 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2022
• Initial Date FDA Received: 02/03/2022
• Date Device Manufactured: 02/08/2016
• 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