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

Model Number V60

Device Problems Loss of Power (1475); Smoking (1585); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 01/21/2021.

Event Description

It was reported that while the ventilator was in use with a patient, smoke belched out of the main body of the ventilator and the device power turned off.When the medical engineer checked the unit, the ventilator did not belch anymore however the room was filled with the burnt smell.The v60 was connected with a power supply multi outlet with grounding and a humidifier was also plugged in the same outlet.The device was taken to the medical engineer's office to be evaluated, but the device did not start up.The device was ventilating a patient when the device stopped ventilating and the patient was swapped to a different ventilator.The patient did not incur additional harm.

Manufacturer Narrative

G4: (b)(6) 2021.B4: (b)(6) 2021.The device was ventilating a patient when the device stopped.Manual ventilation was performed on the patient, and the patient was swapped to a different ventilator.There is no report of additional harm to the patient.The field service engineer (fse) attempted to perform an operational test, but the unit did not startup.The internal inspection was performed and confirmed that some elements of the cpu board were burnt and damaged.Additionally, the fse found illumination failure in the power light-emitting diode (led) and replaced the power switch overlay.The fse replaced the cpu board.Operational testing was performed and passed.The issue is resolved.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 cpu board was returned for failure investigation.A visual inspection and testing was performed.The customer complaint was verified.Root cause is failure of the capacitor c165.

Manufacturer Narrative

B5: h1: correction it was reported that while the ventilator was in use with a patient, smoke emitted out of the main body of the ventilator and the device power turned off.When the medical engineer checked the unit, the ventilator did not emit smoke anymore however the room was filled with the burnt smell.The v60 was connected with a power supply multi-outlet with grounding and a humidifier was also plugged in the same outlet.The device was taken to the medical engineer's office to be evaluated, but the device did not startup.The type of complaint is updated from serious injury to product problem.The device was ventilating a patient when the device stopped ventilating.Manual ventilation was performed on the patient and the patient was swapped to a different ventilator.There is no report of harm to the patient.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11210776
• MDR Text Key: 229088882
• Report Number: 2031642-2021-00263
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 12/28/2020; 06/07/2021; 08/19/2021
• Supplement Dates FDA Received: 04/05/2021; 07/01/2021; 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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.
• Patient Age: 60 YR