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

Catalog Number 15072-000-0005-ASM

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "ac adapters are breaking off at the wall.Delay in therapy:no.Need for medical intervention:no.Patient involvement: no.Death / serious injury: no.Human harm: no.".

Manufacturer Narrative

Distributor information: icu medical, inc.Us service center san jose, ca 95138.Exemption number: e2014005.Q core medical ltd (manufacturer) is submitting the report on behalf of icu medical.

Event Description

The event was reported by a customer from usa: "ac adapters are breaking off at the wall.".

• 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
• MDR Report Key: 5400997
• MDR Text Key: 37271755
• Report Number: 3010293992-2016-00029
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• 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: Other
• Device Catalogue Number: 15072-000-0005-ASM
• Device Lot Number: 16312
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1