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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Event Date 12/12/2023

Event Type  Death  

Manufacturer Narrative

E: (b)(6).(b)(6) japan.(b)(6).

Event Description

Philips received a complaint by the customer on the v60 indicating that while the device was in use on a patient, the patient died on (b)(4) 2023, even though the patient was able to breathe spontaneously.The device kept operating when the event occurred.It was confirmed that the device was being used as it was with no medical intervention taken at the time of the event.No other patient information was disclosed.The hospital did not report any causal relationship, but as the patient's family stated that a cause on the device side may have led to the death.It was confirmed that the device was being used as intended with no medical intervention taken at the time of the event.The hospital did not report any causal relationship, but as the patient's family stated that a cause on the device side may have led to the death.The medical engineer evaluated the device and based on the information currently provided and available, the manufacturer is unable to positively refute any allegation of device malfunction or failure to perform to manufacturer declared specifications due to the absence of device logs at the time of the event in question.It is possible that cause and/or contribution of the device to the patient outcome was present, however, without further substantiating evidence this cannot be confirmed.Further good faith efforts yielded no additional information of clinical relevance in determining the presence of an alleged device malfunction.The device diagnostic report was retrieved and reviewed finding no error or malfunctions, however, due to the device capacity to record only the last 2000 events, the specific date of the event in question could not be reviewed in the report.The device was retrieved and inspected with determination that no parts required replacement.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18894801
• MDR Text Key: 337556007
• Report Number: 2518422-2024-13669
• 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: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 10/30/2017
• 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