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

Model Number V60

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 15june2020.

Event Description

It was reported that the unit had a nurse call alarm test error.There was no patient involvement.The manufacturer's remote service technician performed troubleshooting with the customer.The technician advised the customer to check the resistance at the nurse call (b)(6) which should read between 0-3 ohms.The customer reported that the nurse call (b)(6) read 100 ohms and was jumping around.The technician recommended that the customer try the same test set up on another unit.If the unit passes, the customer was advise to replace the central processing unit (cpu) board on the affected unit.

Manufacturer Narrative

G4: 30jun2020.B4: 30jun2020.Troubleshooting continued and once the customers technician cleaned the rca jack with contact cleaner the reported issue was resolved.The reported problem was resolved with no replacement parts required.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: 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: 10153528
• MDR Text Key: 195569745
• Report Number: 2031642-2020-02083
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1