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

Model Number V60 V60PLUS VENTILATOR

Device Problem Defective Alarm (1014)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator, indicating that the device began to alarm and would not stop.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.The customer informed the remote service engineer (rse) that when the device was plugged into alternating current (ac) power and turned off, both leads on the front bezel are illuminated and solid.When powered on, the device produced a primary alarm failed alarm.The rse reviewed the voltages in the pneumatics screen, and they were all within specification.The rse reviewed the event log and confirmed the occurrence of the primary alarm failed error code and found a power speaker failed error code as well.No other error codes were noted.The rse advised the customer to replace the speaker assembly to correct the device issue.Upon calling the customer back, the rse was informed the customer performed an inspection of the device and they found the wire connecting the speaker assembly to the power management (pm) printed circuit board assembly (pcba) was not secured properly.They requested an onsite visit by a field service engineer (fse) to evaluate the device.On 09-apr-2024, the fse went to the customer site and performed a pre-operational check on the device.The fse confirmed the customer complaint, observing a primary alarm failed alarm occur.The fse confirmed the error code in the device diagnostic report (drpt).The fse then inspected the device and found the speaker connection to the pm pcba disconnected.The fse connected the speaker to the pm pcba and the device then passed a performance verification test (pvt).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

G1 contact office phone: (b)(6).

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19081675
• MDR Text Key: 339842260
• Report Number: 2518422-2024-18797
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 11/19/2020
• 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