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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator indicating that there was a low tidal volume alarm.The device was reported to be in use at the time of the reported problem.No patient harm reported.The customer informed the authorized service provider (asp) that that after the nurse on duty set the parameters for the patient in accordance with the doctor's advice, the patient was put on the ventilator for auxiliary treatment and the device began to alarm "low tidal volume" less than 5 minutes into treatment.The nurse on duty immediately informed the doctor and director of the department to check the device, and the director of the department checked the device alarm.A nurse in the department sent the faulty ventilator to the equipment department for a check.Investigation is ongoing.

Manufacturer Narrative

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

Manufacturer Narrative

A good faith effort (gfe) response from the authorized service provider (asp) received on 23oct2023 stated that onsite service had been completed at the customer site by a 3rd party.The 3rd party repaired the sensor, and the device was returned to service.The report of there being no injuries was confirmed.The patient information from the time of the event was stated to have been asked but unknown.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17954534
• MDR Text Key: 326393096
• Report Number: 2518422-2023-27040
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 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: 10/17/2023
• 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: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Date Device Manufactured: 10/29/2020
• 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