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 Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from canada: "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 only this time the nurse got a shock to her hand as the inside parts touched her hand.Delay in therapy: unknown, need for medical intervention: unknown, patient involvement: yes, death / serious injury: no, human harm: yes." additional information was received on nov.6th, 2015: "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.".

• 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: 5245354
• MDR Text Key: 31975554
• Report Number: 3010293992-2015-00206
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/26/2015

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
• Device Lot Number: 0915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2015
• 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