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

Model Number V60

Device Problem Gas/Air Leak (2946)

Patient Problem Hypoxia (1918)

Event Date 03/25/2024

Event Type  Injury  

Event Description

On 25mar2024, philips received a complaint from the hospital nurse on the v60 ventilator indicating that the device has a low leak alarm and low spo2 on the monitor.A response to a request for further information was received on 11apr2024, and it indicated that the sales representative received an answer from the hospital, and according to a nurse of the hospital, the patient's spo2 dropped to 80% range.The patient was removed from the device and placed onto a backup unit with no further harm or injury noted.The device in question was removed for further investigation and evaluation.Review of the device diagnostic report logs (drpt) revealed several occurrences of the 1203 alarm code on (b)(6) 2024.The evaluation of the unit was unable to replicate the occurrence of the alarm condition.Further analysis of the drpt revealed multiple low inhalation pressure and high respiratory rate alarms (high respiratory rate alarm threshold set to 45 bpm) that had been triggered multiple hours prior to the 1203 alarm condition.Based on the information currently provided and available, causality of the device to the patient outcome has not been confirmed, however, contribution of the device and/or device setup may have been present, as the 1203 diagnostic alarm is designed to trigger when conditions of flow and time are not met appropriately, indicating to the clinical end user that the device is not being allowed proper time for the breathing circuit to expel its gas contents.It is highly likely that the patient breathing dynamics and breath rate >45 contributed to the alarm condition.Further good faith efforts are required to determine root cause.

Manufacturer Narrative

H10: contact office phone number: (b)(6).E1: reporting institution phone number: (b)(6).

Manufacturer Narrative

Further good faith efforts yielded additional information identifying use of a fisher & paykel nivairo interface (size medium) during the event in question.The patient was noted to have experienced an average respiratory rate of 20-23 and an average tidal volume of 1200 ml in the day prior to the event.The additional information presented finds the device was configured in an off-label and unvalidated configuration, as the fisher & paykel nivairo is not an approved interface for the device.Additionally, based upon the information provided and contrasted with the device diagnostic report, the patient's respiratory rate was noted to have significantly increased from the prior day (20-23 bpm) to >45 bpm.The noted tidal volume of 1200 ml per breath is indicative of an unintentional leak, which may be the potential root cause for the change in patient condition and increased respiratory rate.Causality of the device to the patient outcome has not been confirmed, however contribution to the patient outcome has been confirmed as foreseeable use error: use of unapproved interfaces resulting in compromised therapy delivery.

Manufacturer Narrative

H10: the authorized service provider (asp) evaluated the device and was not able to duplicate the issue during a run-in test.Record for the occurrence of a low leak alarm was confirmed on the event log, however, there was no abnormality for the device after an inspection.The repair of the device is still pending.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19101010
• MDR Text Key: 340107146
• Report Number: 2518422-2024-19290
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/16/2024; 04/16/2024
• Supplement Dates FDA Received: 05/01/2024; 05/16/2024
• Date Device Manufactured: 02/08/2016
• 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): Other