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

Model Number BELLAVISTA 1000E

Device Problem Device Sensing Problem (2917)

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

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

The log file analysis shows a few "high rate" and "high leakage" alarms on the date of event, but no information regarding alarm settings or what the patient setup looked like.Vyaire will try to get more details and check if there may be a message on the screen indicating a problem besides the two alarms.From the technical perspective, the suspect device is working absolutely fine, except for slightly low o2 inlet pressure.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 1000e was not picking up respirations in cpap/niv (continuous positive airway pressure/non-invasive) mode.It is unclear whether there was an alarm, and the patient connected to the device was switched to a backup device, delaying treatment.However, no harm is indicated.

Manufacturer Narrative

Vyaire complaint #: pc-(b)(4).Device evaluation: g3, g6, h2, h6, h10.The alarm 221 was triggered shorty after a successful 2p calibration of the o2 cell.An exact root cause is unknown and is being investigated with capa i-ch-20-016.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11399310
• MDR Text Key: 234287377
• Report Number: 3004553423-2021-00878
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149380026
• UDI-Public: (01)07640149380026
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000E
• Device Catalogue Number: 301.100.100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention