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

Catalog Number 15072-000-0005

Device Problems Break (1069); Power Problem (3010)

Patient Problem Electric Shock (2554)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "complaint was brought to my attention by (b)(6) in clinical tech mgmt.Incident was reported that nurse was removing power cord from wall outlet when power cord cover separated and shocked the nurse's hand.Nurse was treated without further complications.Pump treatment information:n/a.Patient involvement: no.Human harm? yes, electric shock".

Manufacturer Narrative

(b)(4).Exemption number, e2014005.Q core medical ltd (manufacturer) is submitting the report on behalf of (b)(4).

Event Description

The event was reported by a customer from usa: nurse shocked by power supply.

• 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: 5643224
• MDR Text Key: 44894911
• Report Number: 3010293992-2016-00125
• 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,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 0915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2016
• 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