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

Model Number V60

Device Problems Tidal Volume Fluctuations (1634); Volume Accuracy Problem (1675)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that there was a 120f "low tidal volume" alarm message.It was reported that there was no patient involvement at the time the issue was discovered.Investigation is ongoing.

Manufacturer Narrative

E1: reporting address line 1: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporter phone number:(b)(6).

Manufacturer Narrative

H10 the customer reported to the remote service engineer (rse) that a "low tidal volume" alarm error message occurred during testing.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed the reported issue and stated that the air flow sensor was broken; however, no repairs were completed by the asp engineer as the customer declined service and repair and chose a third-party vendor.No additional details regarding the issue and repair are available, but the asp engineer verified that the device passed the required performance verification tests per philips standard 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.

• 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: 17687674
• MDR Text Key: 322698456
• Report Number: 2518422-2023-21787
• 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: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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?: No
• Date Manufacturer Received: 11/22/2023
• Date Device Manufactured: 09/12/2013
• 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