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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared, and the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The investigation is ongoing.

Manufacturer Narrative

The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The asp engineer found that the da pcba was faulty and stated that the equipment department of the hospital replaced the da pcba to resolve the issue.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.

• 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: 18564454
• MDR Text Key: 333494965
• Report Number: 2518422-2024-03952
• 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: Biomedical Engineer
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 01/28/2024
• Supplement Dates FDA Received: 02/05/2024
• Date Device Manufactured: 06/07/2016
• 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