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

Model Number	V60
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date (b)(6) 2018.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported unit will not turn on.The device was not in use at the time of the reported event; therefore, there was no patient involvement.

• Brand Name: V60 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 7740698
• Report Number: 2031642-2018-01536
• Device Sequence Number: 1589157
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: 00884838025738
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1