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

Model Number	V60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that unit declared a high blower temperature alarm.There was no patient harm.
Additional Manufacturer Narrative
Date rec¿d by mfr:26apr2019.Correction: event date: approximately: (b)(6) 2019.The manufacturer's field service engineer (fse) performed remote troubleshooting with the customer.The fse recommended that the customer verify the error logged by the device and check the air inlet filter for clogs.If the cooling fan is operating and the filter is not clogged, the fse advised the customer to replace the blower.The customer reported that the air inlet filter was checked and the circulation fan was running; therefore the unit was returned to service.The customer will monitor the unit and contact the manufacturer's technician if any issues occur.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
• 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: 8554659
• Report Number: 2031642-2019-02462
• Device Sequence Number: 11373441
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K082660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1