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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that a 1008 "auto-zeroing of machine and proximal pressure transducers failed" error occurred.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.The device was removed from service, but there was not any reported adverse outcome to patient care or therapy.The biomedical engineer (bme) reported to the remote service engineer (rse) that a 1008 "auto-zeroing of machine and proximal pressure transducers failed" error occurred.The rse advised the bme to reconnect the data acquisition (da)-motor controller (mc) printed circuit board assembly (pcba) cable and retest.The rse also advised the bme to replace the da-mc board cable and da pcba and then test the device for 8 hours.The investigation is ongoing.Hold for wh 1.4.

Manufacturer Narrative

The biomedical engineer (bme) called technical support report that a 1008 "auto-zeroing of machine and proximal pressure transducers failed" error occurred.The remote service engineer (rse) advised the bme to reconnect the data acquisition (da)-motor controller (mc) printed circuit board assembly (pcba) cable and retest.The rse advised the bme to replace the da-mc board cable and da pcba and then test the device for 8 hours.Multiple attempts have been made to try to obtain further information about this case, but no response was received from the bme.It is unknown if the reported issue was confirmed, and the outcome of the reported issue could not be determined.No further information could be obtained.

• 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: 18446834
• MDR Text Key: 332145576
• Report Number: 2518422-2024-00680
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Date Device Manufactured: 08/22/2014
• 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