MAUDE Adverse Event Report: Q CORE MEDICAL LTD. POWER SUPPLY (FIXED HEADS )

Catalog Number 15072-000-0005

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a costumer from usa: "sapphire power cords are broken.Delay in therapy: unknown.Need for medical intervention: unknown." additional information received om nov.20th, 2015: "this is the exact same thing that this customer has filed multiple complaints about.The black housing where the cord plugs into the wall comes apart where the crease is and exposes the wires.".

• Brand Name: POWER SUPPLY (FIXED HEADS )
• Type of Device: POWER SUPPLY (FIXED HEADS )
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: judith antler ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 732388861
• MDR Report Key: 5305248
• MDR Text Key: 33707694
• Report Number: 3010293992-2015-00236
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

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: No Information
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 0915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1