MAUDE Adverse Event Report: Q CORE MEDICAL LTD. Q CORE POWER SUPPLY

Model Number POWER SUPPLY

Device Problem Break (1069)

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

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The complaint was reported by a customer from usa: "problems with the removable power supply prongs were replaced by a non detachable prong.The top portion of the prongs separates from the power supply case and left in the outlet after several usage with the pumps.10 power supply cords were reported to have the problem.No lot number provided since stickers were removed from the cord per hospital policy.Delay in therapy: no.Need for medical intervention: no.Human harm: no.Serious injury or death: no.".

Manufacturer Narrative

(b)(4).Q core medical ltd (manufacturer) is reporting on behalf of hospira.

• Brand Name: Q CORE POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 4250 529; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 4250 529; IS 4250529
• Manufacturer Contact: judith antler ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 0732388827
• MDR Report Key: 4975869
• MDR Text Key: 6360784
• Report Number: 3010293992-2015-00145
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/20/2015

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: Health Professional
• Device Model Number: POWER SUPPLY
• Device Catalogue Number: 05020-150-0160-00
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• 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