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

Model Number V60

Device Problem Date/Time-Related Software Problem (2582)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

This report is based on information provided by philips remote service personnel and is being investigated by the philips complaint handling team.Philips received a complaint on the v60 ventilator indicating that while not in therapeutic use, there was an error code: ¿100b watchdog test failed¿.The remote service engineer (rse) stated that the customer reported a 100b error code displayed and that the watchdog test had failed.The time was not strobed as expected.The customer was instructed to replace the cpu board first and restore the serial number on it, and then replace the mc pcba and flow sensor assembly if needed.The rse provided replace part information for the cpu board.The ordered part is on backorder and the repair for this unit cannot be conducted at this time.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered central processing unit (cpu) board aligns with the recommended repair of the reported malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15880731
• MDR Text Key: 306278937
• Report Number: 2031642-2022-02987
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/29/2022
• Date Device Manufactured: 08/28/2013
• 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