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

Model Number V60 V60PLUS VENTILATOR

Device Problem Unstable (1667)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting the v60 ventilator became detached from the stand during transport.The device was not in clinical use; there was no patient involvement.There was no report of harm or other impact to patient or user.The device did not meet specification for intended use and was removed from service.A philips remote service engineer (rse) evaluated the issue with the biomedical engineer (bme) and confirmed the mounting threads on the bottom of the ventilator were damaged.The rse advised the bme the base assembly would require replacement.The customer requested and received part details for the base assembly and the universal stand.The investigation is ongoing.

Manufacturer Narrative

A philips remote service engineer (rse) evaluated the issue with the biomedical engineer (bme) and confirmed the mounting threads on the bottom of the ventilator were damaged.The rse advised the bme the base assembly would require replacement.The customer requested and received part details for the base assembly and the universal stand.Multiple good faith efforts were made to obtain information regarding the repair activity and operational status with no response from the customer and therefore cannot be determined.It is unknown if any part replacement has been conducted to date.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: 18894972
• MDR Text Key: 337558591
• Report Number: 2518422-2024-13679
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/05/2024
• Date Device Manufactured: 11/21/2011
• 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