MAUDE Adverse Event Report: Q CORE MEDICAL LTD. SAPPHIRE EXTERNAL BATTERY PACK

Catalog Number	15079-111-0001-P2
Medical Device Problem Codes	Overheating of Device (1437); Use of Device Problem (1670)
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 the usa: external battery pack overheating due to possible user error.
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from the usa: external battery pack overheating due to possible user error.

• Brand Name: SAPPHIRE EXTERNAL BATTERY PACK
• Common Device Name: EXTERNAL BATTERY PACK
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 8198948
• Report Number: 3010293992-2018-00124
• Device Sequence Number: 1952683
• Product Code: MRZ
• UDI-Device Identifier: 07290109150086
• UDI-Public: 7290109150086
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K123049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: Lay User/Patient
• Device Catalogue Number: 15079-111-0001-P2
• Device Lot Number: 0215
• Distributor Facility Aware Date: 11/29/2018
• Device Age: 5 YR
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1