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

Model Number V60

Device Problem Device Sensing Problem (2917)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting a patient disconnect alarm occurred on the v60 ventilator.The device was in clinical use.The customer reported an obstruction to the patient's breathing that resulted from the issue.Additional information has been requested.The investigation is ongoing.

Manufacturer Narrative

E1: reporting institution phone: (b)(6).Reporter phone number: (b)(6).

Manufacturer Narrative

A philips authorized service provider (asp) consulted with the customer and reported this event did not negatively influence the patient outcome as previously reported.There was no significant deterioration of the patient oxygenation.The patient was placed on an alternative ventilator for continued therapy.Other clinical details were requested but not provided by the customer.The asp reported the issue was the result of an accumulation of condensation in the pressure tube near the core end.The issue was resolved by replacing a filter and removing the moisture.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.

• 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: 17487987
• MDR Text Key: 320676826
• Report Number: 2518422-2023-19089
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/12/2023
• Date Device Manufactured: 03/02/2020
• 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
• Patient Outcome(s): Life Threatening