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

Model Number V60 V60PLUS VENTILATOR

Device Problem Tidal Volume Fluctuations (1634)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was not producing volumes.It was unknown how the issue was found.No patient or user harm reported.

Manufacturer Narrative

E1: reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).G1: contact office phone: (b)(4).

Manufacturer Narrative

Per the service record, a diagnosis was performed by an engineer, and it was reported that the device required a replacement blower.The repair is pending.

Manufacturer Narrative

H10: the service record was updated to note that the device was not in clinical use when the issue occurred.No patient or user harm reported.A service engineer (se) repaired the device, and replaced the blower assembly.The system meets the specification for the performed service and is returned to use.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19096757
• MDR Text Key: 340342159
• Report Number: 2518422-2024-19123
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 989805658561
• UDI-Public: (01)989805658561
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 05/13/2024
• Supplement Dates FDA Received: 04/18/2024; 05/20/2024
• Date Device Manufactured: 05/13/2020
• 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