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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Model Number 397002-001
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a system malfunction alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
 
Manufacturer Narrative
The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).
 
Manufacturer Narrative
Device history record (dhr) review confirmed that companion 2 driver s/n 10071a was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two new alarms, system malfunction and left vacuum incorrect, in driver's data file.Visual inspection of external and internal components found no abnormalities.Driver passed all areas of functional testing for acceptance at incoming inspection.Observational testing identified that the driver alarmed during the transition from higher to lower vacuum settings and vice versa at patient settings during recorded complaint.A known functional sensor board was installed and functioned without alarm or issue at reported patient settings.This test was repeated with a separate known functional sensor board with the same result.Initial sensor board was installed in a known functional companion 2 driver and failed at the same settings, replicating the original complaint.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; the root cause of the reported system malfunction alarm was determined to be a faulty pressure sensor board.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Patient was switched to a backup driver without any reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
 
Event Description
The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited a system malfunction alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.
 
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Brand Name
SYNCARDIA COMPANION 2 DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e silverlake road
tucson AZ 85713
Manufacturer (Section G)
SYNCARDIA SYSTEMS, LLC
1992 e silverlake road
tucson AZ 85713
Manufacturer Contact
aaron meier
1992 e silverlake road
tucson, AZ 85713
5205451234
MDR Report Key12791350
MDR Text Key281417167
Report Number3003761017-2021-00220
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003107
UDI-Public(01)00858000003107
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/25/2024
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 Number397002-001
Device Catalogue Number397002-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/08/2021
Initial Date FDA Received11/10/2021
Supplement Dates Manufacturer Received11/08/2021
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age42 YR
Patient SexMale
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