MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BIPAP FOCUS VENTILATOR

Device Problem No Display/Image (1183)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

The ventilator screen remains black after being turned on.No reports of patient or user harm/injury.

Manufacturer Narrative

H10: philips received a complaint by the customer on the v60 indicating that the screen was black after the device was turned on.At this time, it is unknown if there was patient involvement at the time the issue was discovered; however, there were not any reports of patient or user harm.The customer reported that the display screen was black after the device was turned on.Per a philips service engineer, manufacturer did not evaluate or repair the device; therefore, it could not be determined if it failed to meet specifications-- no work order was generated because the hospital equipment department repaired the device, but the hospital declined to provide the details.It is unknown what the outcome of the service event was, and no further information could be obtained.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 17082364
• MDR Text Key: 316727770
• Report Number: 2518422-2023-13081
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00989805632691
• UDI-Public: 989805632691
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BIPAP FOCUS VENTILATOR
• Device Catalogue Number: 1028785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Date Device Manufactured: 02/19/2013
• 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