MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problem Increase in Pressure (1491)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator, indicating that there was a high priority alarm.It is unknown if the device was in use at the time of the reported problem.No patient harm reported.The customer informed the remote service engineer (rse) that the high priority high-rate alarm occurred while the breathing rate of the device was set to maximum.The customer was informed that the measured respiratory rate was greater than the high-rate alarm setting, and the alarm escalates to a high priority alarm if the alarm condition persists for more than 60 seconds.The customer stated they planned for preventative maintenance on 30nov2023 and would see if there was a device issue.This investigation is ongoing.

Manufacturer Narrative

On (b)(6) 2023, a philips field service engineer (fse) went to the customer site and performed preventative maintenance (pm) testing on the device.The device passed all testing required by the pm.In a good faith effort (gfe) response from the fse received on (b)(6) 2023, it was confirmed that the high priority alarm the customer had experienced was a result of the customers settings on the device and that the device operated as intended by sounding the alarm when the threshold was reached.There were no problems detected during the service performed by the fse.The fse did not have any further information regarding the device use at the time of the event.

• Brand Name: V60 V60PLUS VENTILATOR
• 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: 18258226
• MDR Text Key: 329623652
• Report Number: 2518422-2023-33343
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/11/2023
• Date Device Manufactured: 08/21/2020
• 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