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

Model Number V60

Device Problems Display or Visual Feedback Problem (1184); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Philips received a complaint from the customer on the v60 ventilator with the following information: the patient was admitted for treatment due to gastrointestinal bleeding.On (b)(6) 2023, the patient underwent an electronic gastroduodenoscopy examination at the bedside.Considering the patient's critical condition, bronchoscopy was necessary to perform hemostasis treatment under gastroscopy.After the patient was fully sedated, tracheal intubation was performed under a visual laryngoscope.During the process of adjusting the parameters of the ventilator, it was observed that the display of each parameter was chaotic, and there was no display.Additionally, the buttons could not be adjusted, and there was an audible and visual alarm, resulting in a ventilator inoperative state.The nursing staff immediately replaced the ventilator and closely monitored the changes in oxygen saturation and oxygenation index.Although the device was in clinical use when the device issue occurred, there was no report of patient or user harm as a result of the reported event.The investigation is ongoing.

Manufacturer Narrative

H10: multiple attempts have been made to try to obtain further information about this case, including the reported issues, impact to patient, device evaluation and repair; however, no response was received.The malfunction could not be confirmed.The complaint will be processed for closure.If additional information becomes available at a later date, the complaint will be reopened, and a supplemental report will be submitted.H11: h6 - device problem, patient outcome and health impact codes have been corrected based on further review of available information.

• 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: 18387387
• MDR Text Key: 331481440
• Report Number: 2518422-2023-37534
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• 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