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

Model Number V60

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date od report: 27aug2020.

Event Description

It was reported to philips that the device's temperature is high.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.

Manufacturer Narrative

G4: 02sep2020, b4: 03sep2020.H11: b5: problem description: it was reported to philips that the device had a high temperature alarm.H11: h6: patient code updated: the device was reported as being in use at the time of the event.The initial reporter confirmed that there was no adverse patient impact.An authorized service personnel(asp) was dispatched to the customer site.The reported issue was confirmed because the user was not familiar with the set-up selection needed to perform as specified.The philips asp performed a set-up, and the device passed with no replacement parts required.The customer's reported problem was then unable to be reproduced.The device successfully passed all required testing.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.

Manufacturer Narrative

G4:08dec2020, b4:08dec2020.H11: b5: it was reported to philips that there was a system setup problem.H11: d4: serial# (b)(6).A remote authorized service personnel(asp) assisted the customer with the re-setup to resolve.The incorrect serial number was entered during the case initiation and has been updated.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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10463597
• MDR Text Key: 205706676
• Report Number: 2031642-2020-03005
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 08/05/2020
• Supplement Dates FDA Received: 09/03/2020; 12/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER