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 12/29/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The event was reported by a customer from usa: "device was plugged into the wall charging.Came time to remove the power adapter from the wall, the casing came off and an exposed adapter was left on the wall.Customer stated that the seams were not properly glued.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: 5373906
• MDR Text Key: 36205258
• Report Number: 3010293992-2016-00022
• 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
• Report Date: 12/30/2015

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: Biomedical Engineer
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 5114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/30/2015
• 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