MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY; EXTERNAL POWER SUPPLY

Catalog Number 295400-001

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom hospital ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom hospital ac power supply is a power supply unit which has an integrated, molded wall input power cord.The hospital ac power supply connects the power adaptor to a wall power outlet.The customer, a syncardia certified hospital, reported that a piece of the outer sleeve of the green connector of the freedom driver hospital ac power supply was broken off.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection confirmed the customer-reported issue as the hypertronics connector outer housing was found to be cracked.It is most likely that the damage to the connector outer housing was caused by an excessive amount of force being applied to the connector and outer housing.This can happen from someone stepping on the unit, something falling on the unit, or someone trying to force the unit into an adaptor from the wrong angle.Despite the observed damage, functional testing confirmed the ac power supply was still able to connect to the power adaptor and power a freedom driver.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9996767
• MDR Text Key: 200777841
• Report Number: 3003761017-2020-00121
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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 Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR