MAUDE Adverse Event Report: V60 VENTILATOR; 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 Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 24nov2020.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer reported a check vent blower temp high alert the device was on a patient at the time of the issue.The ventilator was swapped out and no patient harm was reported.The remote service engineer reviewed the suggested repair for this error.The customer was provided with the part number for the motor controller board for replacement.

Manufacturer Narrative

G4:23mar2021 b4:(b)(6) 2021 the customer reported a blower temperature high alarm, which was found after setting the ventilator up on a patient (reported in mfr report #:2031642-2020-03680).The respiratory therapy team was at the bedside and caught the issue immediately and swapped out the ventilator.There was no medical intervention such as manual ventilation or any other additional harm.Patient details and ventilator settings are unknown.The ventilator was brought to the biomed shop, where a 3rd party biomed changed out the blower.From this point, the ventilator did not leave storage; however, it was deemed ready for use.After the repair was complete, the ventilator was placed on a test lung months later and ran to check that the previous blower temperature high alarm issue had been resolved.During testing, the error reappeared.There was no patient involvement.This mfr report# 2031642-2020-04251 captures the recurrence of the failure.The biomed called the issue into philip's technical support team and was advised to replace the motor controller (mc) printed circuit board assembly (pcba).The in-house biomed replaced the mc pcba, and the issue was resolved.This issue is not reportable since the problem was discovered while the unit was in storage and in possession of the biomedical engineer and, as such, would not cause or contribute to death or serious injury.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10901390
• MDR Text Key: 218723708
• Report Number: 2031642-2020-04251
• Device Sequence Number: 1
• Product Code: MNT
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2009
• 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