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

Model Number V60

Device Problem Unexpected Shutdown (4019)

Patient Problem Respiratory Arrest (4461)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

It was reported that ¿the v60 ventilator suddenly crash down and did not push the fault alarm in time ,result (ing) in patient died of asphyxiation.¿ it was also stated ¿v60 ventilator suddenly crash down no alarm.¿ at this time, this is interpreted to mean that the ventilator shut down unexpectedly and did not alarm, and the patient died due to this event.Investigation ongoing.Further information is being requested.

Manufacturer Narrative

The authorized service personnel replaced the pm pcba 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: philips received a complaint by the customer on the v60 indicating that the device suddenly crash down and did not push the fault alarm in time.Per query response from the authorized service personnel, the device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.Clinical reassessment of the record based on new information.It has now been confirmed that there was no harm or injury related to the event.Therefore, this report will be downgraded from serious injury/adverse event to product problem.

• 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: 16464867
• MDR Text Key: 310487777
• Report Number: 2518422-2023-06049
• 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,User Facility,Company Representative
• 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
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 04/19/2023; 04/19/2023
• Supplement Dates FDA Received: 04/11/2023; 04/27/2023
• Date Device Manufactured: 03/13/2020
• 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