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

Model Number V60

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that there was a low tidal volume.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported patient or user harm.

Manufacturer Narrative

E1 reporter phone number - (b)(6).

Manufacturer Narrative

H10: the device was in use on a patient at the time the reported issue was discovered; however, there was no reported patient or user harm.Additionally, the device was swapped out for another v60, but therapy was not interrupted or delayed.The customer reported to the remote service engineer (rse) that the air volume was low.Per good faith effort (gfe) response, the authorized service provider (asp) engineer could not duplicate the reported issue and confirmed that after testing, the device was normal, the screen display was normal, and there was no alarm.The device passed 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: 17012893
• MDR Text Key: 316664515
• Report Number: 2518422-2023-12291
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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?: Yes
• Date Manufacturer Received: 05/31/2023
• Date Device Manufactured: 02/03/2020
• 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