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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. COMPANION HOSPITAL CART; CIRCULATORY ASSIST DEVICE
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SYNCARDIA SYSTEMS, INC. COMPANION HOSPITAL CART; CIRCULATORY ASSIST DEVICE Back to Search Results
Catalog Number 397003-001
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
Event Type  malfunction  
Event Description
The customer reported that the companion hospital cart received at (b)(4) had a crack on the monitor housing.The customer also reported that it appears that glue was used for repair.This alleged failure mode poses a low risk to a pt because the issue was observed when the hospital cart was not in use by a pt.In addition, it would not prevent a docked companion 2 drive from performing its life-sustaining functions.The companion hospital cart will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
 
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Brand Name
COMPANION HOSPITAL CART
Type of Device
CIRCULATORY ASSIST DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
tucson AZ
Manufacturer Contact
carole marcot, esq vice pres
1992 e. silverlake rd.
ce 2770
tucson, AZ 85713
5205451234
MDR Report Key4769250
MDR Text Key5797635
Report Number3003761017-2015-00153
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 04/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number397003-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2010
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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