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

Model Number V60

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23jun2020.

Event Description

The customer reported a ventilator with no response or poor response to touchscreen input.This event was reported to have occurred during clinical use.There was no allegation of harm associated with this event.Patient information was not made available.

Manufacturer Narrative

G4: 28aug2020.B4: 31aug2020.The customer identified an issue on the touchscreen of the v60 device.The fse confirmed and duplicated the reported issue.The philips international service engineer (fse) replaced the touch screen, and the central processing unit (cpu) board was replaced.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other abnormality was observed.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: 29sep2020 b4: (b)(6)2020 the touchscreen assembly was returned to the manufacturer for failure investigation (fi).The visual inspection of this customer returned touchscreen assembly revealed no evidence of damage or contamination.Failure investigation (fi) technician installed the touchscreen assembly into a fi ventilator to duplicate the reported issue of touchscreen failure.The fi technician identified the touchscreen failure was caused by the ul_lr, ur_ll resistance, and resistance ratio were out of specification.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: 10185732
• MDR Text Key: 196759148
• Report Number: 2031642-2020-02175
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 06/08/2020
• Supplement Dates FDA Received: 08/31/2020; 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.