MAUDE Adverse Event Report: Q CORE MEDICAL LTD. POWER SUPPLY (FIXED HEADS )ASM

Catalog Number 15072-000-0005-ASM

Device Problem Break (1069)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event was reported by a customer from (b)(6): "sn: (b)(4).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 receptacle.Cover for wall plug came apart and nurse contacted wires still connected to 120 volts ac.Shock travelled up nurses arm.Unit removed from use.Type of drug: na.Delay in therapy: unknown.Need for medical intervention: unknown.Patient involvement: yes.Death / serious injury: no.Human harm: no." additional information was received on may 05, 2016: "no serious injury/death occurred as a result of the incident.No medical intervention was required as a result of the incident.The power supply catalogue number is 15072-000-0005 4.The lot number is 0915i ordered some replacement power supplies and the catalogue number on these is 15072-000-0007.There are some differences.".

Manufacturer Narrative

Distributor information: icu medical, inc.Us service center, san jose, ca 95138.Exemption number: e2014005.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 (FIXED HEADS )ASM
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim; netanya, 42505 29; IS 4250529
• MDR Report Key: 5672314
• MDR Text Key: 45751981
• Report Number: 3010293992-2016-00133
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 15072-000-0005-ASM
• Device Lot Number: 0915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1