MAUDE Adverse Event Report: BREAS MEDICAL INC. BREAS Z1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number BREAS Z1

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 06/02/2022

Event Type  Injury  

Event Description

Per customer complaint #(b)(4) the following was alleged: "on (b)(6) 2022 the patient bought the device at (b)(6) to be prepared for a following holiday.Instantly after the usage during her holiday it turned out that the device does not fulfill the expected requirements.During this holiday she suffered from a slight stroke.The medicated doctors are sure that this device is mainly the reason for this occurrence.".

Manufacturer Narrative

Per customer complaint #(b)(4) the following was alleged: "on (b)(6) 2022 the patient bought the device at löwenstein center dortmund to be prepared for a following holiday.Instantly after the usage during her holiday it turned out that the device does not fulfill the expected requirements.During this holiday she suffered from a slight stroke.The medicated doctors are sure that this device is mainly the reason for this occurrence." note: the event is unconfirmed at this point and additional information has been requested from the initial reporter.

• Brand Name: BREAS Z1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BREAS MEDICAL INC.; 16 esquire road; n. billerica, ma 01862; n. billerica 01862
• Manufacturer (Section G): BREAS MEDICAL INC.; 16 esquire road; n. billerica, ma; 01862
• Manufacturer Contact: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 15231228
• MDR Text Key: 297949327
• Report Number: 9617566-2022-00007
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BREAS Z1
• Device Catalogue Number: 2030102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other