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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the device was getting a low tidal volume message.It was reported there was no patient involvement at the time the issue was discovered.The manufacturer's product support engineer (pse) evaluated the device and confirmed the reported problem.It was determined that the flow sensor was faulty and needed to be replaced.Per good faith effort (gfe) response received (b)(6) 2023, no repairs were completed by a manufacturer's product support engineer (pse) as the customer declined service and repair.A "multi-vendor/clinical engineering department" will handle the service call/incident.No additional details regarding the reported issue and its resolution are available.The investigation concludes that no further action is required at this time.The device remains at the customer site.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philip's normal complaint procedure.

Manufacturer Narrative

(b)(6).

• 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: 17389714
• MDR Text Key: 319769426
• Report Number: 2518422-2023-16759
• Device Sequence Number: 1
• Product Code: MNT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60
• Device Catalogue Number: 1076717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• 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