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

Model Number V60 V60PLUS VENTILATOR

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60, indicating that when the device was powered on, the display screen was blank.It was reported that there was no patient involvement at the time the issue was discovered.The biomedical engineer (bme) called technical support to report that when the device was powered on, the display screen was blank.The remote service engineer (rse) recommended that the bme should disconnect and reconnect the liquid crystal display (lcd) cable.The bme informed the rse that the issue could not be duplicated--the bme also shook the device, and the device operated as intended.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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18613413
• MDR Text Key: 334204511
• Report Number: 2518422-2024-05222
• 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

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: Other
• 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: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• Date Device Manufactured: 12/04/2012
• 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