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

Catalog Number 17000-020-0006

Device Problem Break (1069)

Patient Problem Electric Shock (2554)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from (b)(6): "power supply separated at wall receptacle leaving prongs plugged into wall and exposing wires and circuit board inside brick assembly.Nurse received shock when removing plug from wall.Cover for wall plug came apart and nurse contacted wires still connected to 120 volts ac.Shock travelled up nurses arm.Delay in therapy: no, need for medical intervention: no, patient involvement: no, human harm: no".

Manufacturer Narrative

Distributor information: (b)(4).Q core medical ltd (manufacturer) is submitting the report on behalf of icu medical.

Event Description

The event was reported by a customer from canada: disassembly of power supply.

• Brand Name: POWER SUPPLY KIT
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim; netanya, 42505 29; IS 4250529
• MDR Report Key: 5656340
• MDR Text Key: 45224889
• Report Number: 3010293992-2016-00130
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 17000-020-0006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1