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

Model Number V200

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 09/17/2019.The manufacturer's field service engineer (fse) could not repeat the problem.The fse let the machine run for multiple hours in an attempt to show the issue.He could not reproduce the issue.The manufacturer's field service engineer (fse) replaced the mmi pcb (man-machine interface pcb) and digital pcb and tested unit.Now the leds in the buttons do not pass extended self test (est).The fse replaced the front bezel and now all tests pass during est.

Event Description

The customer reported that 100% oxygen randomly turns on by itself.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

Mfr received date: 30 jan 2020.Failure analysis on the returned man machine interface (mmi) board and bezel assembly,v200 (switch circuit panel) shows that the front panel light emitting diode (led) test passed, the reported complaint of the 100% o2 led turns on randomly was not duplicated.No fault was found on this returned switch circuit panel & mmi pcba.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9076233
• MDR Text Key: 165277192
• Report Number: 2031642-2019-09563
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER