MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 40; CONTINUOUS VENTILATOR

Model Number VIVO 40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypoxia (1918)

Event Type  malfunction  

Event Description

Authorized distributor in (b)(6) reports domestic repair of device, replacing the cpu board, after having encountered unspecified failure(s).Based on the info received, the potential risk associated with the reported event is classified as serious since it might result in hypoxia.A defective cpu board could potentially lead to termination of treatment, with high priority alarms as risk mitigations, causing insufficient ventilation of the pt.Based on the info provided at this time, including unk patient outcome, the event is considered reportable per 21 cfr part 803.3.

Manufacturer Narrative

Under european law, pt info is considered confidential and will not be released by the hospital.

• Brand Name: BREAS VIVO 40
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; molnlycke ; SW
• Manufacturer Contact: maria johansson ; foretagsvagen 1; molnlycke SE-43-5 33 ; SW SE-435 33 ; 1868800
• MDR Report Key: 4798407
• MDR Text Key: 5856439
• Report Number: 9617566-2015-00033
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VIVO 40
• Device Catalogue Number: 220100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1