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

Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS

Device Problem Volume Accuracy Problem (1675)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Event Description

Philips received a complaint on the v60 ventilator, indicating that the devices tidal volume was 1.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

H10: it is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.The issue was handled by a third party for maintenance.A third party was entrusted to the maintenance of the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H11:updated contact information, contact office entity, and manufacturing site.

Manufacturer Narrative

This report is being submitted as a correction in response to corrective actions taken by the legal manufacturer.The manufacturer site number was incorrectly selected resulting in incorrect report numbers.A new mdr with the correct manufacturer site selected has been submitted under manufacturer report # 2518422-2023-17255.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16234166
• MDR Text Key: 308352386
• Report Number: 2031642-2023-00286
• Device Sequence Number: 1
• Product Code: MNT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, CHINA OPT: CFLEX, AVAPS
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2023
• Date Device Manufactured: 04/28/2015
• 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