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 01/29/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that although the data acquisition (da) printed circuit board assembly (pcba) was recently replaced, 110c "machine pressure sensor range error" and 1108 "machine pressure sensor autozero failed" errors occurred.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that although the data acquisition (da) printed circuit board assembly (pcba) was recently replaced, 110c "machine pressure sensor range error" and 1108 "machine pressure sensor autozero failed" errors occurred.Prior to replacing the da pcba, the bme was unable to put the device in standby mode.The bme mentioned that the average air was reading 2.1 standard liter per minute (slpm).The remote service engineer (rse) recommended that the bme should replace the flow sensor assembly and provided the bme with the part number of the replacement flow sensor assembly for repair.

Manufacturer Narrative

The biomedical engineer (bme) called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) was recently replaced to resolve a previous proximal port test failed issue, but the 110c "machine pressure sensor range error" and 1108 "machine pressure sensor autozero failed" errors occurred.The remote service engineer (rse) recommended that the bme should also replace the flow sensor assembly as the bme was unable to put the device into standby mode prior to replacing the da pcba.The rse provided the bme with the part number of the replacement flow sensor assembly for repair.Per good faith effort (gfe) response, the bme confirmed that the flow sensor assembly replacement resolved the 110c and 1108 errors and standby issue once it was paired with the old da pcba.The investigation concludes that no further action is required for these issues 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: 18747520
• MDR Text Key: 335873327
• Report Number: 2518422-2024-08808
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/28/2024
• Date Device Manufactured: 04/29/2011
• 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