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

Catalog Number 15072-000-0005

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/24/2015

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 usa: "customer stated they had received a box of replacement power adapters/cords.This batch of adapters seem to be coming apart on their own.the cord did not come out of the box in this condition, it was during a procedure that the cord was being placed into the wall or out.pump treatment information: not applicable type of drug: not applicable.Delay in therapy: no.Need for medical intervention: no.Patient involvement: no.Death / serious injury: no.Human harm: no.".

• Brand Name: POWER SUPPLY (FIXED HEADS )
• Type of Device: POWER SUPPLY (FIXED HEADS )
• 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: 5373901
• MDR Text Key: 36255471
• Report Number: 3010293992-2016-00021
• 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: Other
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 5114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2016
• 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