MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINOUS, FACILITY USE

Model Number BELLAVISTA 1000 US

Device Problem Inaccurate Delivery (2339)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The log file shows that the issue regarding 02 concentration low alarm could be fixed after a calibration of the o2 cell.The customer was asked to perform a 2p calibration of the cell.From a safety perspective, it was recommended to replace the inspiration block to avoid it from reoccurring.No root cause has been determined at this time, since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the bellavista 1000 us was giving out low concentration alarm (alarm 151) during patient use.It was also mentioned that there was a mismatch between what was set and delivered.There was no known patient harm or injury reported in this event.

Manufacturer Narrative

Results of investigation: analysis on the log file shows that the user has not performed a two-point calibration of the oxygen sensor.The user failed to follow manufacturers instruction prior usage of the device.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11399396
• MDR Text Key: 234270382
• Report Number: 3004553423-2021-00872
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)20200909
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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: Health Professional
• Device Model Number: BELLAVISTA 1000 US
• Device Catalogue Number: 301.100.030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1