MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; V60

Model Number V60

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

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was displaying error code 100b (watchdog test failed).There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that that the customer had replaced the cpu for a 100b issue, and now the device was operating as expected with no vent inop or 100b codes.The rse provided the option codes for avaps, cflex and ramp.The customer reported that the options were successfully installed.The system meets the specification for the performed service and is returned to use.

• Brand Name: RESPIRONICS
• Type of Device: V60
• 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: 16742383
• MDR Text Key: 313636943
• Report Number: 2518422-2023-08932
• 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: User Facility
• Reporter Occupation: Other
• 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
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 04/14/2023
• 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