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

Model Number V60

Device Problem Disconnection (1171)

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

Event Date 05/07/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator had 43 different occurrences of error code indicating proximal pressure line disconnect.The ventilator was being used on a patient at the time of the reported event, however, there was no patient harm reported.The customer troubleshot with technical support and could not duplicate the reported issue.The customer was advised to perform performance verification testing.Upon a follow up the customer reported that no issues were found the reported issue was not duplicated and the ventilator passed all testing.

Manufacturer Narrative

B4: 21jul2021.Information was received that the patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.No patient information was provided.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11942535
• MDR Text Key: 254552261
• Report Number: 2031642-2021-03964
• 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

• 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: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/21/2021
• Date Device Manufactured: 12/02/2013
• 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