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

Model Number V60

Device Problems Vibration (1674); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 25mar2020.

Event Description

It was reported that when the ventilator is in standby, the unit is producing high flow which is fluttering.There was no patient involvement.The customer troubleshot with technical support.The customer performed the performance verification test (pvt) and the short self test (sst) performance test failed at the inspiratory positive airway pressure (ipap) of 40 the analyzer was reading 44 which is.4 above tolerance and was also getting a high inspiratory pressure (hip) alarm.The customer noted the blower was vibrating at that time.The customer put a test lung and disconnected it.With the unit on standby and the flow on the analyzer reading 190, the flow was fluttering and the blower was vibrating.The customer replaced the central processing unit (cpu) board, gas delivery system (gds) and the motor controller (mc) board and the issue continues.The customer will replace the blower.

Manufacturer Narrative

G4: 02apr2020.B4: 03apr2020.The customer reported that the hoses that connect between the gas delivery system (gds) and gas outlet and proximal pressure port were accidently switched.The customer connected these hoses to the correct fittings which resolved the 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.

• 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: 9881269
• MDR Text Key: 186682967
• Report Number: 2031642-2020-01024
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1