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

Model Number V60

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29jl2020.

Event Description

During a pre-use check, the medical engineer started the device and an alarm annunciated.The medical engineer noted that the alarm indicator light had failed.There was no patient involvement.The service engineer confirmed the alarm light emitting diode (led) failure with a visual inspection and corresponding check ventilator alarm in the error log.The service engineer also confirmed that the navigation ring was unresponsive and the front bezel, including power switch overlay, needed to be replaced.The touchscreen was functioning normally.

Manufacturer Narrative

G4: 30sep2020 b4: (b)(6) 2020 the field service engineer replaced the front bezel and both issues were resolved.The ventilator was calibrated successfully and passed all required testing.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.

Manufacturer Narrative

G4: 22oct2020, b4: 11nov2020.The bezel,front,english,2nd gen, v60 was returned to failure investigation (fi) for evaluation.Visual inspection of the front bezel revealed no evidence of damage or contamination.The front bezel (membrane/overlay, power, non-english) will be assembled into the fi (user interface) ui assembly & installed into the fi test ventilator in an attempt to duplicate the reported problem.Errors noted.The broken trace on the red (alarm) (light emitting diode) led created the led not to illuminate and caused the error check vent alarm led failed.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: 10341781
• MDR Text Key: 202177292
• Report Number: 2031642-2020-02564
• 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,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1