MAUDE Adverse Event Report: Q CORE MEDICAL LTD. SAPPHIRE POWER SUPPLY KIT - ROW

Catalog Number	17000-132-0008
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from (b)(6): power supply makes a static sparking sound.
Additional Manufacturer Narrative
Distributor information: (b)(6).Exemption number: e2014005.Q core medical ltd (manufacturer) is submitting the report on behalf of icu medical.
Event or Problem Description
The event was reported by a customer from australia: power supply makes a static sparking sound.

• Brand Name: SAPPHIRE POWER SUPPLY KIT - ROW
• Common Device Name: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 7192869
• Report Number: 3010293992-2018-00006
• Device Sequence Number: 917929
• Product Code: MRZ
• UDI-Device Identifier: 07290109150208
• UDI-Public: 7290109150208
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Other
• Device Catalogue Number: 17000-132-0008
• Device Lot Number: 3416
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1