MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 65; CLICK-ON BATTERY

Model Number	004559
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this is a voluntary report of a non-reportable event.No death or serious injury has occurred.The issue does not require remedial action to prevent an unreasonable risk of substantial harm to public health.The reported event has no adverse impact on patient treatment and it is not likely to cause or contribute to death or serious injury.The ventilator and the click-on battery were returned to the manufacturer.Analysis of ventilator log files showed that the click-on battery was not used between (b)(6) and (b)(6) 2021.The battery locking pin was damaged and caused the battery not to latch properly to the ventilator.The battery locking pin was replaced.The ventilator firmware was updated.The device was re-tested and passed.
Event or Problem Description
The healthcare provider reported the following narrative: a click-on battery, which was mounted on a vivo 65 hanging in a stand, fell off.The patient was playing nearby.It was close that the battery could have fallen on the patient and caused injury.The edge of the stand hits the battery lock/button.When the lock is turned, the battery comes loose and falls off.The prescriber belives that there is a fault on the stand causing the battery to come loose.It had happened earlier.There was no patient health impact.

• Brand Name: BREAS VIVO 65
• Common Device Name: CLICK-ON BATTERY
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer Contact: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 14711064
• Report Number: 9617566-2022-00004
• Device Sequence Number: 17496542
• Product Code: NOU
• UDI-Device Identifier: 07321820045594
• UDI-Public: 07321820045594
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: 004559
• Device Catalogue Number: 004559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown