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

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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/14/2021

Event Type  malfunction  

Event Description

It was reported that a ventilator experienced anomalies in numerical values.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The international field service engineer (fse) reported that a ventilator experienced abnormal average machine pressure values.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.There was no delay to therapy reported.The device was evaluated by the fse who confirmed and duplicated the reported issue.The fse replaced the data acquisition board.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.

Manufacturer Narrative

G4:(b)(6)2021 g5:510k: k102985 b4:24jun2021 the visual inspection of this customer returned data acquisition (da) printed circuit board assembly (pcba) revealed no anomalies.A failure investigation (fi) technician installed the data acquisition (da) printed circuit board assembly (pcba) into a fi ventilator to duplicate the reported issue of abnormal proximal pressure values.Fi technician identified that the abnormal proximal pressure values could not be verified or reproduced.No fault was found.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11815409
• MDR Text Key: 250323711
• Report Number: 2031642-2021-03700
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• 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: 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: 04/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• 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