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 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Philips received a complaint from the customer, reporting a machine and proximal pressure sensors failed message occurred on the v60 ventilator.The device was not in clinical use.There was no report of harm or other patient / user impact.

Manufacturer Narrative

H10: a manufacturer's product support engineer (pse) evaluated the device and confirmed diagnostic code 1007 (machine and proximal pressure sensors failed) indicated a problem with the data acquisition (da) printed circuit board assembly (pcba).The pse inspected the device further to isolate the da pcba failure and found the pcba data cable was disconnected.The cable was reconnected, and the device was left running to see if the fault persisted.There was no recurrence, and a complete performance verification testing (pvt) was completed.The client's configuration was maintained.The device was operational 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: 18722487
• MDR Text Key: 336185870
• Report Number: 2518422-2024-07986
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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

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: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/04/2024
• Date Device Manufactured: 10/03/2017
• 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