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

Model Number V200 VENTILATOR

Device Problem No Display/Image (1183)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Event Description

Philips received a complaint on the v200 ventilator, indicating that the device screen went black.The device was reported to be in use at the time of the reported problem.The patient information from the time of the event was stated to have been asked but is unknown.In a good faith effort (gfe) response from the authorized service provider (asp) received on 25apr2024, it was clarified that the patient did not experience any harm as a result of the black screen device issue.The clinical settings of the device, device configuration of attachments and accessories, any device error codes, and patient diagnosis were all stated to have been asked for, but unknown.The asp stated that the device ceased giving therapy during the issue but confirmed that the patient did not experience harm or require medical intervention.The asp provided that the hospital replaced the liquid crystal display (lcd) of the v200 ventilator, and the device was able to return to full functionality and return to use.The replaced lcd screen will not be returned to philips for evaluation.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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19214991
• MDR Text Key: 341413098
• Report Number: 2518422-2024-23930
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V200 VENTILATOR
• Device Catalogue Number: 1060264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• 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