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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of this report: 17 jun 2020.

Event Description

It was reported there was an oxygen supply fault during continuous built in testing.There was no patient involvement.

Manufacturer Narrative

G4: 06oct2020.The remote service engineer advised the customer to change the o2 percentage to different levels during testing and monitor the o2 delivery with an external sensor.The customer confirmed one occurrence of the oxygen supply fault error in the significant error log.The customer ran the high and low pressure leak tests which passed and checked o2 levels at different settings with v60 running for over half a day without error.No repairs were made as the error was resolved through testing and the device was returned to use.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: 10165056
• MDR Text Key: 196065659
• Report Number: 2031642-2020-02114
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 0884838009851
• UDI-Public: (01)0884838009851
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1