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

Model Number V200

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Read Input Signal (1581); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event : (b)(6) 2020.Date of report: 26feb2020.

Event Description

The customer reported touchscreen failure.The keypad test failed during est (extended self test) and the unit displayed air valve liftoff failure.There was no patient involvement.The manufacturer¿s field service engineer (fse) confirmed the reported touch screen failure, key pad test failed during (est) extended self test and an error referencing an air valve lift off failure when switching on the machine issue.During further investigation, the fse could not duplicate the keypad test failure.The manufacturer¿s field service engineer (fse) replaced the touch screen ( assembly touch frame) to address the reported problem of the touch screen failure, and error referencing an air valve lift off failure when switching on the machine.During further investigation, the fse could not duplicate the keypad test failure, so the keypad overlay was returned unused.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.

• 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: 9756762
• MDR Text Key: 184458407
• Report Number: 2031642-2020-00634
• 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: 01/31/2020

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: Health Professional
• 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: 01/31/2020
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2011
• 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