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

Catalog Number 17000-020-0006

Device Problem Break (1069)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from (b)(6): "hi (b)(6) we are still having problems with the sapphire cords breaking.I know that you had shipped us new and different ones but one of those ones broke and i sent it to biomed yesterday from pacu.I was just up on birthing unit now and one of the nurses pulled the cord out of the outlet yesterday and it fell apart in her hand (this happened to you too (b)(6)) only this time the nurse got a shock to her hand as the inside parts touched her hand.(b)(6) has the pump and was not in her office when i was there.It was an epidural pump.We need to get this pump and find out if it is the older or new cord.All of the old cords need to be replaced.(b)(6) i believe it scared her and she felt a "stinging" sensation on her hand when the power cord fell apart in her hand.I do not believe there was any mark left on her hand or any visible damage to her hand.I will have (b)(6) confirm this and add anything else as i believe she was present with the staff member when it happened.Yes, the power supply had been in use since the pumps were launched in (b)(6) of this year.This is correct.Her hand was red immediately after the incident but cleared up very quickly.I was not with her when it happened but was there shortly after the incident.Delay in therapy: unknown.Need for medical intervention: unknown.Death / serious injury: no.Human harm: yes." after re-evaluated before closing, the event marked as reportable on dec.24th, 2015.

• Brand Name: POWER SUPPLY
• Type of Device: POWER SUPPLY
• 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: 5379348
• MDR Text Key: 36483014
• Report Number: 3010293992-2016-00025
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2015

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: 17000-020-0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2016
• 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