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 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint from the customer, reporting a machine and proximal pressure sensor failed message occurred on the v60 ventilator.The issue was found in the sales office prior to customer delivery, therefore was not in clinical use.There was no harm or patient / user impact.The device did not meet specification for intended use.

Manufacturer Narrative

H10: a manufacturer's product support engineer (pse) evaluated the device and confirmed the record of "vent inoperative 1007 machine and proximal pressure sensors failed" (diagnostic code 1007) in the event log.The pse replaced the data acquisition (da) printed circuit board assembly (pcba) and da-motor control (mc) cable.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.

Manufacturer Narrative

H10: the removed data acquisition (da) printed circuit board assembly (pcba) was returned to the product investigation lab (pil) for analysis.The pil technician installed the daq into a pil v60 standard test bed (stb) for testing.Visual inspection of the component revealed no anomalies.Multiple reboots were performed on the stb with the suspect da pcba installed.The tech verified that the e/c 1007 could not be duplicated during the stb operation or rebooting of the stb.The pil technician verified that the suspect da pcba passed all pressure accuracy testing (test 4) from the service manual.The product investigation lab could not replicate problem on the da pcba.The removed da-motor control (mc) cable was also returned to the pil for analysis.No discernable issues were noted in the visual inspection of the cable.The stb operates without issue or error code with the suspect cable installed.This includes the reboot of the device with cable installed.All required voltages (3.3vdc, 5vdc, 12vdc, and 35vdc) are present on the pcbas.Test ventilator with returned cable ran for extended period with no errors.The pil investigation concluded with a no problem found determination.The customer complaint could not be verified.

• 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: 18667770
• MDR Text Key: 334900305
• Report Number: 2518422-2024-06235
• 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 Operator: Other
• 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: 01/25/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 04/24/2024
• Supplement Dates FDA Received: 02/12/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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