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U.S. Department of Health and Human Services

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

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IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINOUS, FACILITY USE Back to Search Results
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.
 
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Brand Name
BELLAVISTA
Type of Device
VENTILATOR, CONTINOUS, FACILITY USE
Manufacturer (Section D)
IMTMEDICAL AG
gewerbestrasse 8
buchs, 9470
SZ  9470
MDR Report Key11399310
MDR Text Key234287377
Report Number3004553423-2021-00878
Device Sequence Number1
Product Code CBK
UDI-Device Identifier07640149380026
UDI-Public(01)07640149380026
Combination Product (y/n)N
PMA/PMN Number
K163127
Number of Events Reported1
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 NumberBELLAVISTA 1000E
Device Catalogue Number301.100.100
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/02/2021
Initial Date FDA Received03/02/2021
Supplement Dates Manufacturer Received03/18/2021
Supplement Dates FDA Received06/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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