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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 17june2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

The customer reported breakage on blower mounting screw of base assembly.There was no patient or user harm reported.

Event Description

The customer reported breakage on blower mounting screw of base assembly.There was no patient or user harm reported.

Manufacturer Narrative

G4: 08oct2019.B4: 09oct2019.The customer replaced the base assembly.No other abnormality was confirmed but the following parts were replaced as regulated by periodic maintenance 2 procedure to prevent failure: blower assy., lithium-ion battery, cooling fan, oxygen inlet filter, tubing kit, air inlet filter and cooling fan filter.The unit was checked overall, cleaned, run in tests and functionally tested.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: 8705908
• MDR Text Key: 148276512
• Report Number: 2031642-2019-03892
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: 06/09/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/09/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1