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

Model Number V60

Device Problem Unexpected Shutdown (4019)

Patient Problem Hypoxia (1918)

Event Date 01/09/2024

Event Type  Injury  

Event Description

The customer submitted a voluntary report to fda through fda's medwatch program regarding a complaint on the v60 ventilator indicating that the device stopped functioning while in use on a patient.It was reported that the patient¿s o2 (oxygen) saturation dropped briefly to the 50s and had to use a bag valve mask to stabilize the patient until a new bipap could be connected.This was documented under mdr report # mw5150198, which was forwarded to philips by fda on january 31, 2024.Further information regarding the reported event has been requested.

Manufacturer Narrative

This record was reviewed by the post market surveillance clinical expert for clinical assessment due to the customer reporting that during clinical and therapeutic use of the v60 ventilator, an allegation of unspecified ventilator inoperability ("stopped functioning") resulted in patient desaturation of peripheral oxygenation (spo2) to approximately 50% range and subsequently requiring administration of manual ventilation.During the period of manual ventilation, the patient was noted to have been stabilized while a backup ventilator was requisitioned (make/model unspecified).Multiple attempts have been made to try to obtain further information about this case, but no response was received from the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened and a supplemental report will be submitted.

• 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: 18662299
• MDR Text Key: 334799402
• Report Number: 2518422-2024-06129
• Device Sequence Number: 1
• Product Code: MNT
• 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: Health Professional
• Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/11/2024
• 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): Required Intervention