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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13oct2020.

Event Description

The customer reported getting an error 35v alarm on the main screen when in use.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.The manufacturer's technical services (ts) confirmed the reported issue.Advised caller per service manual revision k, of the suspect the (motor controller) mc pcb.The customer replaced the defective mc board to address the reported problem.The unit successfully passed the required performance verification test.

• 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; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10672183
• MDR Text Key: 212482957
• Report Number: 2031642-2020-03682
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2009
• 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