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

Model Number V60 V60PLUS VENTILATOR

Device Problem Volume Accuracy Problem (1675)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the device had a low tidal volume.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The customer reported to the remote service engineer (rse) that the tidal volume was not going up.The rse recommended onsite service, advised that the flow sensor assembly should be replaced, and provided the customer with the part number of the flow sensor assembly.An authorized service provider (asp) engineer was dispatched onsite to evaluate and repair the device.

Manufacturer Narrative

E1: initial reporter info: (b)(6).

Manufacturer Narrative

H10: an authorized service provider (asp) engineer was dispatched onsite to evaluate and repair the device.Upon arrival, the asp engineer confirmed the reported issue and verified that the device alarmed for carbon dioxide repeat inhalation.The asp engineer then put the device into diagnostic mode, checked the alarm logs, and found that the 1203 (alarm message: low leak-co2 rebreathing risk) error code was logged.The asp engineer diagnosed the issue as a gas module failure according to the maintenance manual and replaced the air & o2 flow sensor assembly.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: 17698597
• MDR Text Key: 322832764
• Report Number: 2518422-2023-21933
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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?: No
• Date Manufacturer Received: 10/19/2023
• Date Device Manufactured: 01/27/2021
• 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