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

Model Number V60

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that while the ventilator was on a patient it stopped, restarted and alarmed.The unit was being used on a patient at the time the reported issue occurred however, there was no patient harm.

Manufacturer Narrative

The manufacturer¿s international service technician confirmed the reported reboot issue caused by a failure that occurred on the data processed in the cpu pcba while the unit was in use.Also a blank line in the error log led to the belief that there was a temporary failure of the power management (pm) pcba.The manufacturer¿s international service technician replaced the cpu pcba and the power management (pm) pcba to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.The determination could not be made that the device failed to meet specifications.Though the unit was being used on a patient at the time the reported issue occurred, there was no patient harm.There is no relationship of the device to the reported problem.The customer returned cpu pcba and power management (pm) pcba were tested and no failures were identified.

• 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
• MDR Report Key: 7474335
• MDR Text Key: 107013168
• Report Number: 2031642-2018-00924
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1