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

Model Number V60

Device Problems Crack (1135); Component Missing (2306); Device Displays Incorrect Message (2591); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23apr2020.

Event Description

The customer reported that the ventilator showed an error indicating a low co2 rebreathing risk, and they experienced a noisy blower.There was no patient involvement.The customer sent the ventilator in for repair.At the repair facility the issues as reported by the customer were confirmed, a noisy blower as well as a co2 rebreathing alarm.Additionally, it was found the top enclosure had cracks, there were 3 feet missing from the unit, and there was a worn tubing kit.The issues will be resolved by replacing the gas delivery system, the blower and grommets, 3 new feet, and a new top cover.A preventative maintenance kit was ordered as well.

Manufacturer Narrative

G4:25mar2021 b4:(b)(6)2021 in the initial call, the customer (biomed) had also reported that the unit could not enter standby mode.The replaced gas delivery system (gds) was received for internal failure analysis the customer's complaint was verified.It was determined that the root cause was failure of the air flow sensor, caused by the "u1" component drifting out of calibration.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: 9992752
• MDR Text Key: 188991388
• Report Number: 2031642-2020-01513
• 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: 04/06/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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