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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Deliver (2338)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) called technical support to report that during unit setup, the unit oxygen (o2) only worked with the o2 e-cylinder tanks on the cart, and there was no o2 function upon connecting to o2 wall source.The remote service engineer (rse) advised the bme that the external o2 manifold or o2 hose may need to be replaced as a precaution.Per good faith effort (gfe) response, the bme confirmed that the complaint could not be duplicated as the device appeared to be working properly with wall source o2.No fault was found.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

Phone number (b)(6).

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that during unit setup, the unit oxygen (o2) only worked with the o2 e-cylinder tanks on the cart, and there was no o2 function upon connecting to o2 wall source.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that during unit setup, the unit oxygen (o2) only worked with the o2 e-cylinder tanks on the cart, and there was no o2 function upon connecting to o2 wall source.The investigation is ongoing.

• 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: 19144391
• MDR Text Key: 340814878
• Report Number: 2518422-2024-20984
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,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: 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: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/22/2024
• Date Device Manufactured: 08/23/2021
• 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