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

Model Number V60

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

The customer reports that the bottom half of the touchscreen is not responding.The customer contacted product support and reported has performed the touch screen calibration in the unit and states bad touch was detected.Product support reviewed the touch screen recall and noted that this unit did not appear to be on the recall.Product support provided the customer a copy of f (b)(4).Product support advised the customer to replace the touch screen.It is unknown if the unit was in use on a patient, but there was no patient harm reported.

Manufacturer Narrative

There was no patient involvement or harm.Following the evaluation of the device, the customer replaced the touchscreen to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.Although requested to be returned, the removed component was not received for evaluation at this time; therefore, the root cause at the component level could not be determined.An evaluation will be performed if the removed component is received, and an additional report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11886534
• MDR Text Key: 253003050
• Report Number: 2031642-2021-03831
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

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?: Yes
• Distributor Facility Aware Date: 04/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 09/15/2021
• Date Device Manufactured: 02/02/2017
• 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