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

Catalog Number	05020-160-0001-P2
Medical Device Problem Code	Failure to Charge (1085)
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 usa: "external battery packs, not working draining the internal battery and not using the external battery also causing battery acid to leak.Two external causing battery acid leak.No physical damage.No known incidence of mishandling.The leaking occurred in the external batter pack.The battery pk was sent to bio med department and was cleaned up for reuse.The battery pack still seems to only work sometimes.Patient involvement: yes, human harm: no, delay in therapy: yes, medical intervention needed: no.".
Additional Manufacturer Narrative
(b)(4).Exemption number, e2014005.
Event or Problem Description
The event was reported by a customer from usa: external battery pack not working, causing delay in treatment.

• Brand Name: BATTERY PACK
• Common Device Name: BATTERY PACK
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• MDR Report Key: 6184436
• Report Number: 3010293992-2016-00294
• Device Sequence Number: 89427
• Product Code: MRZ
• UDI-Device Identifier: 07290109150086
• UDI-Public: 7290109150086
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: 05020-160-0001-P2
• Distributor Facility Aware Date: 08/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2016
• Supplement Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1