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

Model Number V60

Device Problem Failure to Charge (1085)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 12oct2020.

Event Description

It was reported the battery would not charge.The device was in clinical use at the time of the issue, however no patient harm was reported.

Manufacturer Narrative

G4:(b)(6) 2020 b4:(b)(6) 2020 the field service engineer confirmed the reported issue with the battery.It was also noted during the evaluation that the device can only work when connected to the electrical current.The field service engineer (fse) determined the battery needed to be changed.The fse changed the battery and the issue was resolved.After this repair, the device passed testing.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

G4:29dec2020 b4:(b)(6)2020.The issue was found during perrformance verification testing and there was no patient involvement.As such there is no potential for death or serious injury and is not reportable to the fda or eu.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

G4:29dec2020 b4:(b)(6)2020 c10: updated the device was not in clinical use at the time of the issue.The device was in performance verification testing and there was no patient involvement.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: 10667784
• MDR Text Key: 211902756
• Report Number: 2031642-2020-03670
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• 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: 09/21/2020

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: 09/21/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 09/21/2020; 09/21/2020
• Supplement Dates FDA Received: 12/01/2020; 12/29/2020; 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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