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

Model Number V60

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 29jan2021.

Event Description

The customer stated that the device was on a patient when a diagnostic error code "blower temperature too high" came up and stated that device was over heating.The customer reported that the unit was in use on a patient at the time of the reported device behavior at medical intervention.The patient was bagged and intubated.

Manufacturer Narrative

G4:21apr2021 b4:(b)(6)2021 a philips authorized representative evaluated the device.The reported issue was confirmed and traced to a faulty motor controller pcba and blower.During the device evaluation, the engineer noted that the device generated a blower temperature high alarm on (b)(6)2021.No diagnostic report was provided for review.The technician replaced the motor controller pcba and blower.The device passed all performance verification tests and was returned to the customer.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital¿s intermediate care unit on an unknown date with an admitting diagnosis of coronavirus (covid 19).Relevant medical history included multiple co-morbidities; details not provided.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator in average volume-assured pressure support (avaps) mode; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on an unknown date, the patient was receiving therapy via the v60 device, the patient had a respiratory rate in the 40s, the device generated a blower temperature too high (1002) alarm, the device entered an inoperative state and stopped providing therapy, the patient experienced an event of decreased peripheral capillary oxygen saturation (spo2); values not reported, hospital staff then intubated the patient, administered mechanical ventilation; details not provided, and the patient was admitted to the intensive care unit (icu).No relevant laboratory data was reported.It is unknown if the patient remains intubated, on mechanical ventilation, and admitted to the icu.The reporter stated that the ventilator had no items such as curtains, placed on or around the device.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.

Manufacturer Narrative

The blower motor assembly were received by the failure investigation laboratory for analysis.The blower motor was visually inspected, no obvious dust or debris on the unit, no signs of mechanical damage of physical mishandling, no obvious indications of electrical overstress or overheating, no signs of wear on connector or cabling, and the blower spins freely.Customer complaint verified.The root cause is a failure of the blower assembly.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11254674
• MDR Text Key: 229572993
• Report Number: 2031642-2021-00362
• 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,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER