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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 11feb2019.(b)(4).The service engineer (se) inspected the device and verified the reported issue.The se replaced the touchscreen to resolve the reported issue.

Event Description

It was reported that av60 ventilator experienced a "touch screen problem".The ventilator was not in use on a patient at the time of the reported event.The event date was not specified; estimate used.

Manufacturer Narrative

Date of event : (b)(6) 2019, date rec¿d by mfr : 13feb2019.Clarification was received that the touchscreen was unresponsive.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.

Event Description

It was reported that the touchscreen on a v60 ventilator was unresponsive.The ventilator was not in use on a patient at the time of the reported event.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report : 23jul2019, date rec¿d by mfr :01jul2019.A touch screen assembly was return for analysis.Failure analysis on the returned touch screen shows that the ul_lr and ur_ll resistance and ul_lr/ ur_ll 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: 8326310
• MDR Text Key: 135889342
• Report Number: 2031642-2019-00821
• 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,Followup
• Report Date: 01/18/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 01/17/2019; 01/17/2019
• Supplement Dates FDA Received: 02/19/2019; 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1