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

Model Number V60

Device Problem Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the device had error 1105 (alarm led) in the event log, and the alarm led illuminated red.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The customer was given a quote for the part number and pricing for a replacement power switch overlay.

Manufacturer Narrative

G4:10jun2021.B4:30jun2021.The customer ordered a replacement power switch overlay to be replaced onsite by the customer.No onsite service was requested, and the case was closed.A supplemental report will be submitted if new information is received.

Manufacturer Narrative

B4:07sep2021.It is unknown if the device was in clinical use at the time of the event.The customer could not be reached for additional information regarding how the device was being used when the problem was observed.There was no report of patient or user harm.No part was received for evaluation.Previous investigations have shown that excessive engagement or pressure contact over the light emitting diode (led) while attempting to engage the switch due to the proximity of the led to the switch may cause a separation of the led to the encapsulant.This is subjective to the operator of the equipment which is why this is not a universal or catastrophic failure of all units.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11418761
• MDR Text Key: 234975412
• Report Number: 2031642-2021-03003
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: 00884838009868
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• 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: 1053615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Distributor Facility Aware Date: 02/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 06/10/2021; 08/13/2021
• Supplement Dates FDA Received: 06/30/2021; 09/07/2021
• Date Device Manufactured: 06/16/2010
• 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