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

Model Number V60 V60PLUS VENTILATOR

Device Problem Unexpected Shutdown (4019)

Patient Problem Hypoxia (1918)

Event Date 11/23/2023

Event Type  Injury  

Event Description

Philips received a complaint from the customer reporting an unspecified error occurred on the v60 ventilator causing the device to become inoperative.The device was in clinical use.The patient experienced a temporary decrease in saturation partial oxygen (spo2) level as a result.The device was exchanged for an alternative ventilator and supplemental oxygen was provided to the patient for recovery.A manufacturer's product support engineer (pse) evaluated the device and reported the issue could not be confirmed in the device event log.The investigation is ongoing.

Manufacturer Narrative

E1: (b)(6).

Manufacturer Narrative

A manufacturer's product support engineer (pse) evaluated the device and reported the issue of "vent inoperative 1009 pressure regulation high" was confirmed in the event log.The reported issue, however, could not be duplicated in testing.Functional tests were performed for verification.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.

• 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: 18248175
• MDR Text Key: 329501298
• Report Number: 2518422-2023-32997
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/13/2023
• Date Device Manufactured: 05/23/2017
• 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): Required Intervention