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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

E1: reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Event Description

Philips received a complaint from customer reporting check vent: proximal pressure sensor auto-zero failed" alarm occurred on the v60 ventilator.The device was in clinical use.There was no report of harm.The ventilator was exchanged for another v60 ventilator and there was no report of delay of therapy.The customer restarted the device which cleared the error.

Manufacturer Narrative

H10: a manufacturer's product support engineer (pse) evaluated the device and reported the problem could not be duplicated in testing.However, an occurrence record of "check vent: proximal pressure sensor auto-zero failed" (diagnostic code: 110b) was confirmed in the event log.The pse determined solenoid valves 3 and 4 need to be replaced.The customer was provided a service proposal for repair but to date, has not approved further service.The repair proposal expired but the repair will be performed when the proposal is approved by the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

H10: a manufacturer's product support engineer (pse) evaluated the device and could not duplicate the reported issue in testing.However, since an occurrence record of "check vent: proximal pressure sensor auto-zero failed" (diagnostic code 110b) was confirmed in the event log, the solenoid valves 3 and 4 were replaced.The device was operational and returned to service after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18688960
• MDR Text Key: 335155955
• Report Number: 2518422-2024-06940
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 05/14/2024; Not provided
• Supplement Dates FDA Received: 05/14/2024; 05/29/2024
• Date Device Manufactured: 05/15/2018
• 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