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

Model Number V60

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 03apr2020.

Event Description

The customer reported unit was emitting an odor.Thermal damage to the (central processing unit) cpu board was observed.There was no patient or user harm was reported.

Manufacturer Narrative

Pma/510k: (b)(6) 2020.Date of report: (b)(6) 2020.The manufacturer's field service engineer (fse) confirmed the reported issue.Confirmed cpu pcba has burned components.The fse replaced the defective cpu and power management board to address the reported problem.The unit successfully passed the required performance verification test.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: 21sep2020.B4: 30sep2020.A cpu pcba (central processing unit, printed circuit board assembly) was returned for analysis.A visual inspection of the returned component was performed, and no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician confirmed the reported odor and damage.The root cause was determined to be the failure of the c165 component resulting in disposition of sediment across neighboring components.No fault was found with cpu (central processing unit) operation.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: 9924711
• MDR Text Key: 187254411
• Report Number: 2031642-2020-01165
• Device Sequence Number: 1
• Product Code: MNT
• 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,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1