MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V200

Device Problems Image Display Error/Artifact (1304); Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

The customer reported touchscreen is not functioning.The service technician confirmed the reported issue and indicated lines were appearing in the display and touch was not functioning.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The service technician replaced the touchframe assy and the mmi (man-machine interface) pcba (printed circuit board assembly) to correct the reported issue.The device successfully passed performance specification testing after the repair was completed.

• Brand Name: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 9821110
• MDR Text Key: 187948983
• Report Number: 2031642-2020-00873
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/22/2020

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: No Information
• Device Model Number: V200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2020
• Initial Date FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2013
• 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