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

Catalog Number 17000-020-0006

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

Patient Problem Electric Shock (2554)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

(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 usa: "the reporter stated that the housing of the power supply was cracked.He mentioned that the black piece on the end came off when the nurse tried to pull it off from the socket that also caused the nurse to get shocked.Though asked if there's any harm done to the nurse, he said none.No other information provided.Please send replacement to the address above and put attn to (b)(6) / biomed.Delay in therapy:no.Need for medical intervention:no.Patient involvement: no.Death / serious injury: no.Human harm: no.".

Manufacturer Narrative

(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: 5415591
• MDR Text Key: 37621899
• Report Number: 3010293992-2016-00038
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 17000-020-0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2018
• 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