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

Model Number BELLAVISTA 1000 US

Device Problem Pressure Problem (3012)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.However, it was reported by vyaire technical support that when the unit turned on, alarm technical failure 318, inspiration block failure occurred.Advised that new inspiration block needs to be replaced and the o2 cell has to be calibrated.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 bellavista 1000 us with low pressure, low volumes and o2 (oxygen) concentration alarm.The customer confirmed that there was no patient harm associated with the event.

Manufacturer Narrative

Results of investigation: the suspect device was not returned for investigation but was evaluated by a field service representative onsite.Vyaire medical determined root cause as due to user fault (not following instructions).Instructed the customer that the o2 cell had to be calibrated prior use of device.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 11661164
• MDR Text Key: 247698636
• Report Number: 3004553423-2021-00955
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149388183
• UDI-Public: (01)07640149388183(11)20201030
• 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: 03/16/2021

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: 03/16/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 07/04/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1