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

Model Number V60

Device Problem Overheating of Device (1437)

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

Event Date 03/10/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported the ventilator was brought in stating the motor was overheating.It is unknown whether there was an alarm at the time of the issue.The ventilator was in use with a patient at the time of the issue and the ventilator was swapped out for a different ventilator.No additional patient or user harm was reported.The bme spoke with a remote service engineer (rse).The bme ran the unit for an hour and a half without any issue.The rse advised the bme to check the error log and the bme found error code which relates to blower temperature high.The bme said the air inlet filter was not dirty enough to cause a heat build up.The fan filter is clean and the circulation fan is running.A follow up visit was performed by a field service engineer (fse) who replaced the motor controller board.The fse performed testing and the ventilator passed so the issue was resolved.

Manufacturer Narrative

G5:510(k)#: k102985 b4:01jul2021 the motor controller board was returned for failure investigation.Visual inspection and testing was performed and the customer complaint cannot be verified.Returned product passed testing.No fault found.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11645832
• MDR Text Key: 244788606
• Report Number: 2031642-2021-03339
• 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: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/10/2021
• Date Manufacturer Received: 06/21/2021
• Date Device Manufactured: 04/20/2020
• 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