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

Model Number V60 PLUS

Device Problem Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

It was reported to philips that the touchscreen was not working.The device was not in use at the time of the event.There was no report of patient or user harm.

Manufacturer Narrative

The customer was provided with a quotation on 18-feb-2021 for onsite evaluation to determine any repair necessary for the device.The customer did not accept the quotation, and it subsequently expired.The root cause of the reported condition could not be determined because no additional information can be obtained from the customer.If the device is returned for evaluation, a supplemental report will be submitted.Conclusion: based on information provided and/or service performed, the customer¿s alleged malfunction could not be confirmed.No response was received for the quotation for onsite service and/or repair.The device was not being used for treatment when the reported event occurred.H3 other text : customer declined the quotation for repair.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11418187
• MDR Text Key: 234926367
• Report Number: 2031642-2021-03006
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,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 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1