MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Defective Component (2292); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 22dec2020.

Event Description

The customer reported requesting the part number for the v60 (central processing unit) cpu board version (b)(4).There was no patient involvement.The manufacturer's technical services(ts) confirmed the reported issue.The customer was advised they will have to use teraterm to restore v60 serial number.The customer replaced the defective cpu and reinstalled the (average volume assured pressure support) avaps, cfles, ramp, (high flow therapy) hft options to address the reported problem.The unit successfully passed the required performance verification test.

Manufacturer Narrative

H11:b5: the customer reported that the o2 disconnected.Upon start-up, the user received a "vent.Inop 100b watchdog test failed" error.H10: good faith efforts (gfe) were performed for further detail regarding the event; it was reported that the user received an "o2 disconnected" error.The user then turned off the unit, and upon turning the unit on, a "vent inop 100b watchdog test failed" error was observed.The responder then reported that during evaluation, the alleged malfunction could not be duplicated.The responder consulted with philips tech.Support, and it was determined that responder needed to order and replace the cpu.The cpu was replaced, and software version 3 was installed.After resetting all vent options and performing an ovp, the unit operated properly.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11060327
• MDR Text Key: 223772663
• Report Number: 2031642-2020-04697
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2018
• 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