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

Model Number V60

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.

Event Description

The customer reported the unit is not switching on at all and a burning smell was coming from the device.There was no patient involvement.

Manufacturer Narrative

G4: 05jun2020.B4: 05jun2020.The manufacturer's field service engineer (fse) confirmed the reported issue.The fse replaced the power management board but during power up the power supply started smoking.The unit failed testing and therefore will require the (gas delivery system) gds to be replaced.Service on unit is still pending until gds is received.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

G4: 30jul2020 b4: (b)(6)2020 the manufacturer¿s field service engineer (fse) performed troubleshooting.The fse replaced the power management board, but during power-up, the power supply was smoking.The fse replaced the power supply and pm board, but smoking was reported from the pm board.The fse replaced the mc board, pm board, cpu board, and the power supply.After this repair, the unit was turned on and was reported not to be smoking.The unit was tested, and a battery failed error was observed.The fse replaced the battery.The battery was reported to have a manufacture date of 05-2013.Per the v60 service manual, rev k, the battery is recommended to be replaced every five years.It has been determined that the (gas delivery system) gds does not require replacement.Full performance tests were carried out, and the unit passed all testing.The unit was confirmed to meet specifications and was returned to the customer for use.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 central processing unit printed circuit board assembly (cpu pcba) was returned for analysis.The visual inspection of the central processing unit printed circuit board assembly (cpu pcba) revealed no evidence of damage or contamination.The returned component was evaluated and the customer complaint was not verified.No fault found with returned cpu pcba, based on the review of the returned material the device met specification.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 9940646
• MDR Text Key: 188407042
• Report Number: 2031642-2020-01232
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• 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: 05/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• 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