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

Model Number V60

Device Problems Failure to Power Up (1476); Material Integrity Problem (2978)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

E1: reporting address state: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).During bench servicing, multiple damage caused by a device drop, storage, and/or maintenance were found.The customer has accepted a quote for replacement parts and bench services to repair the device.The investigation is ongoing.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00377.All information from the original report(s) has been transferred to this report.

Event Description

Philips received a complaint on the v60 ventilator, indicating that the device was out of order.It is unknown if the device was in use at the time of the reported problem.No patient harm reported.The customer stated that the device was out of order.An approval has been provided to the customer for replacement parts and bench services.A good faith effort (gfe) is being completed to provide clarification on the original device issue/allegation and the device use at the time of the reported issue.

Manufacturer Narrative

H10: the customer confirmed white coated rear bezel part was requested but is currently backordered.The replacement of the other material ordered replacement parts and repair for this unit cannot be conducted at this time due to the part(s) being on back order due to covid-19 global event, this service spare part is considered critical need and will be monitored for ordered quantity aiming to preserve stock for all customers.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered, white coated rear bezel, aligns with the recommended repair of the reported malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

• 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: 17439635
• MDR Text Key: 320240016
• Report Number: 2518422-2023-17898
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: 00884838009844
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

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
• Device Catalogue Number: 1053613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 10/25/2023
• Date Device Manufactured: 03/07/2011
• 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