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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY Back to Search Results
Catalog Number 295400-001
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient reported that this freedom ac power supply was damaged.The customer also reported that no information was provided as to how it was damaged.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.The freedom driver has a redundant power source of onboard batteries.The freedom ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).Please note, the part number has been corrected from 295050-001 to 295400-001.
 
Event Description
The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the patient reported that this freedom hospital ac power supply was damaged.The customer also reported that no information was provided as to how it was damaged.There was no reported adverse patient impact, and the patient was provided with a replacement hospital ac power supply.The hospital ac power supply was returned to syncardia for evaluation.Visual examination of the hospital ac power supply revealed that the connector was disassembled, and there was no adhesive on the connector mating threads.Because there was no adhesive applied on the connector mating hreads, the connector cover was able to come loose and the connector became disassembled.The disassembly is most likely the damage reported by the customer.The connector was reassembled and tested, and the hospital ac power supply passed all performance testing.The hospital ac power supply was returned to the supplier for repair to have adhesive applied to the mating threads of the connector.This failure mode poses a low risk to the patient because it did not prevent the patient's freedom driver from performing its life-sustaining functions.The freedom driver continued to function as intended.In addition, the freedom driver has a redundant power source of onboard batteries.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
 
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Brand Name
SYNCARDIA FREEDOM AC POWER SUPPLY
Type of Device
AC POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5626388
MDR Text Key45283647
Report Number3003761017-2016-00161
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 04/13/2016
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 Lay User/Patient
Device Catalogue Number295400-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/13/2016
Initial Date FDA Received05/03/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2015
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 Age62 YR
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