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

Model Number V60 V60PLUS VENTILATOR

Device Problem Tidal Volume Fluctuations (1634)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2023

Event Type  Injury  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint by the customer on the v60, indicating that during the use of the ventilator, it was observed that the tidal volume was low, and the patient's vital signs decreased.

Manufacturer Narrative

H10: there was no patient harm, confirmed that it had no effect due to the failure.The patient circuit was replaced, with no further medical intervention provided to the patient, and unknown if there was a delay.Per good faith effort (gfe) response received 09/21/2023, it was confirmed that the hospital refused to provide any further information about the patient use of the device.Multiple attempts were made to obtain additional clinical and patient information to confirm that an adverse event occurred and the severity of the event, however, these attempts were unsuccessful, and it cannot be confirmed if the device event occurred during patient use and resulted in life-threatening situation requiring intervention.Given the reported clinical scenario, the reported device event will be considered an adverse event because live-saving therapy/treatment has been interrupted and or delayed and may have led to a deterioration in the state of the health of the patient.The manufacturer's product support engineer (pse) who evaluated the device confirmed that the aging of the patient circuit caused the machine failure.The customer replaced the patient circuit to resolve the reported issue.The device passed required performance verification tests per philips standards 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.

Manufacturer Narrative

H11: patient outcome code grid has been corrected, since it was alleged the patient's vital signs decreased.

• 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: 17781281
• MDR Text Key: 323837376
• Report Number: 2518422-2023-23858
• 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

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 09/27/2023
• Supplement Dates FDA Received: 09/28/2023; 09/28/2023
• Date Device Manufactured: 11/21/2014
• 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
• Patient Outcome(s): Required Intervention