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

Model Number V60

Device Problems Failure to Calibrate (2440); Communication or Transmission Problem (2896)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00043.All information from the original report(s) has been transferred to this report.

Event Description

Philips received a complaint on the v60 ventilator, stating that the unit had a check vent alarm- 111c, indicating the analog to digital converter (adc) failed.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The customer stated that they had just replaced the flow sensor assembly and the data acquisition (da) printed circuit board assembly (pcba) for an issue of the volume not being displayed.After those part replacements is when the user encountered the 111c.The customer stated it is occurring with both the new and old parts installed.The customer stated that the motor controller (mc) pcba was removed for the flow sensor assembly replacement and the blower was no longer running.The customer was advised to remove the mc pcba and check all connectors/components for damage.If none was found, then reinstall the original flow sensor and da pcba.If the alarms do not clear, then the customer was told to replace the mc pcba.If the alarms did clear, then the customer should reinstall the new components.If the alarms then reoccur with the new parts installed, then the customer was instructed to contact philips parts to request a new da pcba under parts warranty.Multiple good faith efforts (gfe) were attempted to obtain further information/confirmation of the troubleshooting, part order, part replacement, and resolution.No response or further information was received from the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

On 11jul2023, the bench service engineer (bse) confirmed that the device was showing the 111c, 1127, and 1201 error codes.The bse determined that a defective power management (pm) printed circuit board assembly (pcba) was causing the error codes and would need to be replaced.The investigation is ongoing.

Manufacturer Narrative

H10: on 02may2024, the bench service engineer (bse) replaced the power management (pm) printed circuit board assembly (pcba).Following the repair of the device, the bse completed performance verification testing which the ventilator passed to confirm it met specification for the performed service and could be returned to the customer ready for use. 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17388809
• MDR Text Key: 319806009
• Report Number: 2518422-2023-16702
• 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,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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 07/11/2023; 05/02/2024
• Supplement Dates FDA Received: 08/09/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• 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