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

Model Number V60

Device Problem Unexpected Shutdown (4019)

Patient Problem Cardiac Arrest (1762)

Event Date 04/01/2022

Event Type  Death  

Event Description

Philips had received a notification of a patient death occurring on (b)(6) 2022.The patient was noted as "high-risk for post-operative respiratory failure due to their medical history" and "depended on non-invasive ventilation with the philips v60 to maintain adequate respiratory function, life-sustaining oxygenation of their organs and tissues, and hemodynamic stability in the post-operative setting." the patient was admitted to a medical institution on (b)(6) 2022 for planned c3-c6 anterior cervical discectomy and fusion.The procedure was stated to have been performed without incident and the patient was transferred to the pacu (post anesthesia care unit) with alleged risk of respiratory swelling, due to pre-existing conditions of obesity and osa (obstructive sleep apnea).The patient was administered morphine for pain management (dosage unspecified) and subsequently transferred to the institution's medical/surgical unit.The patient at this time had positive pressure therapy discontinued and was placed onto 4 l/min via nasal canula with additional orders for continued pulse oximetry and etco2 (end tidal co2) monitoring with oxygen protocol, notification of respiratory therapy if spo2 falls below 90% or if etco2 is =50, discontinuance of spo2 and etco2 monitoring if no events ware noted.At approximately 2342 on (b)(6) 2022, the patient's nasal canula was removed and the patient was placed on to the v60 ventilator (rationale for medical therapy change undisclosed).At 0125, the patient's non-invasive interface was noted to have become dislodged and triggered appropriate audible and visual alarms from the v60.At 0134, (b)(6) 2022, the patient's non-invasive interface required replacement (rationale unspecified).At 0209, the patient's vitals were recorded as heart rate 99, respiratory rate 20, spo2 92%.At 0230, the patient was administered 2 mg (milligram) of morphine for pain management.Within the following 1.5 hours, the patient was noted to have desaturated <90%, and the patient had gone into cardiac arrest.It was alleged that the external vitals monitor had either been ignored or deliberately silenced during the event.It was also alleged that between 0233 and 0412 the v60 ventilator ceased to ventilate and had gone into a "silent shutdown" whereby no audible or visual alarm was emitted by the device.It was unknown how long the patient had been in cardiac arrest before emergency life saving measures were taken.The patient was successfully resuscitated and subsequently intubated and placed onto a mechanical ventilator (make/model unspecified).It was noted that the eeg (electroencephalogram) showed that the patient had suffered catastrophic brain injury, due to lack of oxygen to the brain (anoxic brain injury), and had suffered a broken rib, and pneumothorax of the left lung due to chest compressions during cpr (cardiopulmonary resuscitation).The patient was subsequently removed from life-support on (b)(6) 2022 at the family's request.Further information is required in order to determine root cause and confirmation of device cause and/or contribution to the patient outcome.This investigation is ongoing.

Manufacturer Narrative

H10: g: contact information (b)(4).

• 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: 19075673
• MDR Text Key: 339759676
• Report Number: 2518422-2024-18487
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• 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): Death; Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male