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
Date of event: (b)(6) 2020.Date of report: 01may2020.
Event or Problem Description
The customer reported the unit stopped delivering patient breaths.The device did have patient involvement at the time the issue was discovered, however, there was no patient or user harm reported.The field service engineer (fse) could not duplicate customer's complaint.Performed diagnostic report (drpt) download.No continuous built-in test (cbit), power on self-test (post) or error codes were found.Found that unit would intermittently switch between running on internal battery and alternating current (a/c)power restored.The fse recommended to customer that the power management printed circuit board assembly (pcba) should be replaced.Customer declined manufacture support and will order part and repair in house.
Additional Manufacturer Narrative
G4: 12oct2020.B4: 13oct2020.The customer confirmed the unit has been repaired but did not clarify repair details.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.
Additional Manufacturer Narrative
G4: 24apr2020.B4: 14may2020.The customer ordered the power management board for the unit, pending repair.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.
Additional Manufacturer Narrative
G4: 28may2020.B4: 29may2020.The customer indicated there was leak test problem as well.The field service engineer (fse) recommended the power management board for the power problem and a patient outlet port for the leak problem.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.
Additional Manufacturer Narrative
G4:24nov2020.B4:25nov2020.The power management (pm) board was replaced to resolve the reported issue.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: 10019171
• Report Number: 2031642-2020-01613
• Device Sequence Number: 3387249
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: No Information
• 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: 04/14/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 04/14/2020; 04/14/2020; 04/14/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/14/2020; 06/01/2020; 10/13/2020; 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER