MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Improper Device Output (2953)

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

Event Type  malfunction  

Event Description

The international customer reported v60 lcd panel was flickering and it was hard to see.The unit was being used on a patient at the time the reported issue occurred; however, there was no adverse effect.

Manufacturer Narrative

The power management (pm) board and lcd (liquid crystal display) assembly were returned to the vent manufacturing facility for evaluation.Visual inspection of the lcd assembly revealed no evidence of damage or contamination.The pm board and lcd assembly were installed in the test ventilator in an attempt to duplicate the reported problem.The test ventilator display screen flickered.The pm board was removed from the test vent and further evaluated.During debugging it was found that the fb1 pin 1 and pin 2 shorting measuring at 29.5 ohms.Found solders bridge between the fb1 pins.The excess solder under the fumonisin b1 (fb1) was removed and fb1 was soldered back on the pm board.Pm board was re-installed on the test vent and testing repeated.This time the test vent display did not flicker.The root cause for the display to flicker was determined to be due to shorting of pins 1 and 2 of fb1.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,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: denyse murphy ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 5717538
• MDR Text Key: 48132306
• Report Number: 2031642-2016-01413
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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
• Patient Age: 85 YR
• Patient Weight: 56