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)(6).Q core medical ltd (manufacturer) is submitting the report on behalf of hospira.

Event Description

The event was reported by a costumer from usa: "new enhanced sapphire power cord came apart.Wires separated from connector delay in therapy: unknown need for medical intervention: unknown death/serious injury: no.".

• 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: 5313029
• MDR Text Key: 33935196
• Report Number: 3010293992-2015-00243
• 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: 11/25/2015

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: 5014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2015
• 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