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

Catalog Number 15072-000-0005

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "the other five (lot # 0915) are damaged at the end that connects to the 120v outlet (mostly the plastic housing came apart.One has the black and white wires pulled out from the plastic housing).Delay in therapy: unknown.Need for medical intervention: unknown.".

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: plastic housing of adaptors came apart.

• 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
• MDR Report Key: 5400999
• MDR Text Key: 37237890
• Report Number: 3010293992-2016-00030
• 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: 01/06/2016

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
• Device Lot Number: 0915
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1