MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit had an error message "auxiliary alarm supply" failed.Based upon the information provided, the device was not in clinical use or providing therapy at the time of the event reported.No harm or injury has been indicated or alleged.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device, the customer reported the unit had an error aux alarm supply failed.The unit was disassembled at this time.The rse advised the customer to reassemble the unit for troubleshooting.The customer reported that the mc board, pc board, and the power supply have been replaced.The customer verified that the error code was 1115.The rse advised the customer to verify the output of the power supply and the 12 and 24 volts were present.The customer noted that the information from the flow sensors was not on the vent info screen and the voltages on the pneumatics screen was missing.The customer checked and verified that the cable from the mc board to the data acquisition board was not connected correctly so the cable was reconnected and the voltage and missing information corrected but the code continued.The rse advised the customer to replace the cpu board and discussed the reloading of the serial number and the power on hours using teraterm.The rse advised the customer once the serial number of the replacement cpu board was known to give call back for option codes.It is unknown if any parts or repair has been conducted in relation to the alleged complaint.Attempts to obtain further information are currently pending.

Manufacturer Narrative

Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event; however, no patient harm or injury was reported.The customer replaced the cpu to resolve the reported issue.No other anomaly was reported.

Manufacturer Narrative

The cpu was returned for failure analysis.Visual inspection observed no anomalies.The returned cpu passed bench and cycle testing with no errors occurring.The customer complaint cannot be verified, no fault was found.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12437110
• MDR Text Key: 270292963
• Report Number: 2031642-2021-04855
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/11/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/24/2021; 02/24/2022
• Supplement Dates FDA Received: 11/18/2021; 03/21/2022
• Date Device Manufactured: 03/27/2012
• 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