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

Model Number V60

Device Problem Self-Activation or Keying (1557)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23sep2020.

Event Description

The customer reported that while the unit was in storage it powered itself on.The manufacturer's field service engineer (fse) provided remote support and educated the customer that the depleted lithium battery is for the battery voltage to rise which can cause the device to power up.The customer noted that the battery % is 80%.The fse advised the customer to check the battery date and found date of 2011.The fse advised the customer to replace the battery, and if it powers itself on again to replace the user interface printed circuit board assembly.

Manufacturer Narrative

G4:20jan2021.B4:21jan2021.Multiple good faith efforts were made to obtain additional information on the repair/service the device has been unsuccessful.If additional information is received, the complaint will be reopened, and a follow-up report submitted.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

G4:03feb2021.B4:04feb2021.The customer confirmed the battery was replaced and the issue was 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10575729
• MDR Text Key: 208719316
• Report Number: 2031642-2020-03425
• 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: 09/04/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/04/2020; 09/04/2020
• Supplement Dates FDA Received: 01/21/2021; 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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