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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the proximal pressure sensor failed to reset automatically.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.It was observed that the data acquisition (da) printed circuit board assembly (pcba) was faulty and transferred to the equipment department for maintenance.Additionally, the device was swapped out for another ventilator.The customer reported that the proximal pressure sensor failed to reset automatically.

Manufacturer Narrative

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

Manufacturer Narrative

H10: per good faith effort (gfe) response received 06dec2023, the authorized service provider (asp) confirmed that the data acquisition (da) printed circuit board assembly (pcba) was damaged.The asp stated that unspecified spare parts have been ordered but not yet replaced.Multiple attempts have been made on 27nov2023, 06dec2023, and 15dec2023 to try to obtain further information about this case regarding the repair, but no response was received from the asp.It is therefore unknown what the outcome of the reported issue was, and no further information could be obtained.This file is closed and can be reopened if new information becomes available.

• 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: 18104547
• MDR Text Key: 327773104
• Report Number: 2518422-2023-29725
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Date Device Manufactured: 07/18/2017
• 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