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

Model Number	N/A
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.Q core medical ltd (manufacturer) is submitting the report on behalf of icu medical.
Event or Problem Description
The compliant was reported by a customer from (b)(6).Charging issue.

• Brand Name: INTEGRATED POWER SUPPLY US
• Common Device Name: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 9254256
• Report Number: 3010293992-2019-00095
• Device Sequence Number: 11703105
• Product Code: MRZ
• UDI-Device Identifier: 07290109150208
• UDI-Public: 7290109150208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 15072-000-0010
• Distributor Facility Aware Date: 10/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1