MAUDE Adverse Event Report: RESPIRONICS; V60 VENTILATOR

Model Number V60

Device Problem Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).

Event Description

It was reported that the customer was discontinuing therapy from a patient and the screen was unresponsive.There was no patient harm or injured as a result of the event.The customer reported that they held the power button and the unit shout off per customer.The customer performed the touchscreen calibration and the checked the unit and found no issues with the touchscreen operation.The remote service engineer recommended the touchscreen assembly be replaced and the software must be updated to 2.10 or higher.The customer elected to replace the user interface.

Manufacturer Narrative

B4: 08jul2021.The user interface assembly was replaced and no further issue on the device was reported.

Manufacturer Narrative

The user interface (ui) assembly was returned for failure investigation.Visual inspection of the user interface assembly revealed evidence of touchscreen cracked and shattered glass refers to record (b)(4).Touchscreen with cracked or shattered glass cannot be tested since the glass justification has a resistive coating, which, if broken, makes the touchscreen nonfunctional.

• Brand Name: RESPIRONICS
• Type of Device: V60 VENTILATOR
• MDR Report Key: 11398791
• MDR Text Key: 234411881
• Report Number: 2031642-2021-03001
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Distributor Facility Aware Date: 02/15/2021
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 06/28/2021; 09/15/2021
• Supplement Dates FDA Received: 07/08/2021; 10/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2010
• 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