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 01/02/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that a 110b "the proximal pressure is not measured, and pressure-related alarms are compromise" error occurred.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) initially called technical support to report that a 1203 "low leak-co2 rebreathing risk" alarm error message during unit setup.The bme stated that the flow sensor assembly was replaced, and preventive maintenance (pm) was performed; however, the device alarmed again, and the bme found a 110b error code in the event log.The remote service engineer (rse) advised the bme to try removing and reseating the data acquisition (da) printed circuit board assembly (pcba) and check the pin alignment between the solenoids and da pcba.The rse also recommended that the bme should check the internal exhalation port for any obstructions.The investigation is ongoing.

Manufacturer Narrative

The bme stated that the flow sensor assembly was replaced, and preventive maintenance (pm) was performed; however, the device alarmed again, and the bme found a 110b error code-the proximal pressure is not measured, and pressure-related alarms are compromised in the event log.The remote service engineer (rse) advised the bme to try removing and reseating the data acquisition (da) printed circuit board assembly (pcba) and check the pin alignment between the solenoids and da pcba.The rse also recommended that the bme should check the internal exhalation port for any obstructions.Per good faith effort (gfe) response, the bme stated that the reported issue was confirmed.The bme ordered the replacement data acquisition (da) to motor controller (mc) cable, performed the cable replacement, ran the device for several hours, successfully completed preventive maintenance, and verified that the issue was resolved.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.

Manufacturer Narrative

H11- h10: per follow-up good faith effort (gfe) response, the biomedical medical engineer (bme) stated that the reported issue was confirmed and discovered that there was a misalignment of the data acquisition (da) printed circuit board assembly (pcba).The bme therefore ordered the replacement da to motor controller (mc) cable for repair and noted that there was no defective part return as the cable did not have any faults.The bme the device alarmed and the bme found a 110b error code-the proximal pressure is not measured, and pressure-related alarms are compromised in the event log.The remote service engineer (rse) advised the bme to remove and reseat the data acquisition (da) printed circuit board assembly (pcba) and check the pin alignment between the solenoids and da pcba.The rse also recommended that the bme should check the internal exhalation port for any obstructions.Per good faith effort (gfe) response, the bme stated that the reported issue was confirmed and discovered that there was a misalignment of the da pcba.The bme therefore ordered the replacement da to motor controller (mc) cable, performed the cable replacement, ran the device for several hours, successfully completed preventative maintenance, and verified that the issue was resolved.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: 18579758
• MDR Text Key: 333730359
• Report Number: 2518422-2024-04301
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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,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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 01/29/2024
• Supplement Dates FDA Received: 01/29/2024; 02/01/2024
• Date Device Manufactured: 03/26/2018
• 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