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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
Catalog Number P/N 397002-001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2023
Event Type  malfunction  
Event Description
The customer, a syncardia certified hospital, reported the companion 2 driver is not recognizing batteries when in the device.Different batteries were substituted but the problem persisted.
 
Manufacturer Narrative
The driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
 
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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 Key17270186
MDR Text Key318668567
Report Number3003761017-2023-00099
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberP/N 397002-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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