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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07oct2020.

Event Description

It was reported to philips that the blower stopped working while in use.The device was in use at the time of the event.The device was swapped and there was no adverse event to the patient.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer reported that error codes were in the significant event logs.The customer stated they swapped out the pm pcba and confirmed the pm pcba resolved the issue.The customer requested onsite service from a philips field service engineer (fse) to replace the pm pcba.A philips fse was dispatched to the customer site.

Manufacturer Narrative

G4: 28oct2020.B4: 29oct2020.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer reported that error codes 35 v supply failed and auxiliary alarm supply failed were in the significant event logs.The customer stated they swapped out the pm pcba and confirmed the pm pcba resolved the issue.The customer requested onsite service from a philips field service engineer (fse) to replace the pm pcba.A philips fse was dispatched to the customer site.The fse replaced the power management (pm pcba) board and the device passed all required testing.The device fully meets specification and was returned to service.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: 10645744
• MDR Text Key: 211474332
• Report Number: 2031642-2020-03618
• 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: 09/16/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER