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

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

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/19/2021

Event Type  malfunction  

Event Description

The customer reported that the unit's touchscreen was out of alignment.The customer reported there was no patient involvement.The manufacturer's product support engineer (pse) evaluated the unit and confirmed the reported issue.During the oxygen concentration accuracy test it was found that the values were off.Pse replaced the unit's touchscreen to resolve the reported issue.To resolve the oxygen concentration testing issue, the flow sensor assembly was replaced.The unit passed required performance verification tests per philips standards.

Manufacturer Narrative

The reported issue was during preventive maintenance, which is outside of clinical use and, therefore, not reportable.The touchscreen assembly was returned for failure investigation.Visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.The ul_lr and ur_ll resistance were out of specifications.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11532369
• MDR Text Key: 241936245
• Report Number: 2031642-2021-03068
• 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,Followup

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Distributor Facility Aware Date: 02/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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