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

Catalog Number 15072-000-0005-ASM

Device Problem Break (1069)

Patient Problem Electric Shock (2554)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "catalog#: 16355-02; (b)(6).Clinical technology engineer, (b)(6) reported that 2 power cords had separated at the power supply end of cord where it is plugged into the wall.Unfortunately, a patient unplugged the cord and received a shock that caused blisters and required medical attention.Acknowledgement letter will be sent to customer once cmr number is available.Fnlim 01/28/16.Pump treatment information: na.Type of drug: na delay in therapy: unknown.Need for medical intervention: unknown.Patient involvement: yes.Human harm: yes, patient received an electric shock.".

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "a patient unplugged the cord and received a shock".

• 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: 5465636
• MDR Text Key: 39205773
• Report Number: 3010293992-2016-00062
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 15072-000-0005-ASM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2016
• 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