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

Model Number V60

Device Problem Intermittent Loss of Power (4016)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

The customer called in due to the respiratory therapist (rt) reporting that the ventilator turned off and on by itself.The device was being set up for patient use.There was no patient harm.The customer spoke with a remote service engineer (rse) on the first call and a said with unit not running and connected to ac power the power switch led is illuminated amber and the battery led is flashing.Customer reviewed the event log and found codes logged indicating the unit was operating on battery power and produced a low battery alarm.The unit was connected to ac power for less than a minute then running on battery power again.Battery voltage is 12.5 vdc per the pneumatics screen.The rse advised the ventilator turning off then back on caused by depleted battery.Rse advised to fully charge the battery as indicated by a steady battery led then to do electrical safety, internal battery and power fail tests per the service manual before placing back into service.Rse also advised to discuss with rt and advise that after a low battery alarm the unit should be connected to ac power long enough to charge the battery before being placed on patient.The customer called in a second time and said while allowing the battery to charge the unit powered on by itself.The rse advised to remove dc power and monitor it while connected to just ac power to see if it powers on by itself.If it does to replace the power management (pm) pcba.If not then reconnect dc power and allow it to fully charge (battery had been depleted to 12.5 vdc) then reevaluate to see if it powers on by itself.If it does to replace the battery.Customer called a third time and said the ventilator will power on and off by itself, on battery and on ac power.Customer attempted to remove battery and just run unit on ac power.With unit just on ac power unit was still powering on and off by itself.Customer requested bench repair.

Manufacturer Narrative

The ventilator was received at the bench repair center.The bench engineer (be) confirmed the customer complaint.The unit won't power on.The user interface 2nd gen board is damaged and needs to be replaced.The 2nd gen lcd cable is needed as well.Additional problems found: the front bezel is not taking calibration and the rear bezel is cracked.

Manufacturer Narrative

The bench engineer replaced the user interface, front bezel, rear bezel, pm kit, shipping box, and cable to the lcd.The touchscreen was calibrated, and the issue was resolved.

Manufacturer Narrative

A user interface board was returned to the manufacturer for analysis.An investigation was performed, and the product analysis technician reported that the root cause was contamination of the pcb in the area of fb21.The customer complaint was verified.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12781180
• MDR Text Key: 281146268
• Report Number: 2031642-2021-05485
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup

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: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/11/2021; 01/14/2022; 03/15/2022
• Supplement Dates FDA Received: 12/09/2021; 02/07/2022; 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2014
• 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