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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018.On 10jan2019.International udi: (b)(4).Additional information regarding the event has been requested.A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported that the device turned off without alarm.The device was in use at the time of the event.The patient was transferred to an alternate source of ventilation at the time of the event.The customer was able to turn on the device after removal of the battery.The event date was not specified; estimate used.

Manufacturer Narrative

Report date: 18jan2019.Date rec'd by mfr: 17jan2019.The field service engineer (fse) evaluated the device.The reported condition could not be duplicated by the fse.The ventilator passed all testing and operated within the manufacturing specification.As a precautionary, the power management (pm) printed circuit board assembly (pcba) and the power supply were replaced.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: 8235860
• MDR Text Key: 132918296
• Report Number: 2031642-2019-00232
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN