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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC. SYNCARDIA COMPANION HOSPITAL CART
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SYNCARDIA SYSTEMS, LLC. SYNCARDIA COMPANION HOSPITAL CART Back to Search Results
Catalog Number 397003-001
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2023
Event Type  malfunction  
Manufacturer Narrative
The companion hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
 
Event Description
The customer, a syncardia certified hospital, reported that they were performing system check hospital cart and found a ground pin broke within the hospital cart impacting the ability of the locking power cord to stay in contact with other pins.
 
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Brand Name
SYNCARDIA COMPANION HOSPITAL CART
Type of Device
HOSPITAL CART
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 Key16414851
MDR Text Key310010566
Report Number3003761017-2023-00015
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 Non-Healthcare Professional
Type of Report Initial
Report Date 02/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number397003-001
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/29/2013
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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