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

Model Number POWER SUPPLY

Device Problem Break (1069)

Patient Problem Electric Shock (2554)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Q core medical ltd (manufacturer) is reporting on behalf of hospira.

Event Description

The complaint was reported by a customer from usa: "ac adapter fell apart dr.(b)(6) was shocked when she pulled power supply out of outlet.Power supply fell apart delay in therapy: no.Need for medical intervention: no.".

• Brand Name: Q CORE POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 42505 29; IS 4250529
• Manufacturer Contact: judith antler ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 0732388827
• MDR Report Key: 4987541
• MDR Text Key: 22375197
• Report Number: 3010293992-2015-00149
• 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: Health Professional
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POWER SUPPLY
• Device Catalogue Number: 17000-020-0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2015
• 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
• Patient Outcome(s): Other