MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES MEDLINE MULTI FUNCTION DEBIBRILLATION ELECTRODE; RADIOLUCENT DEFIBRILLATION ELECTRODE ADULT/CHILD

Model Number	MDSPHY100
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is report is being submitted retrospectively as the result of an fda inspection in (b)(6) 2021.As a corrective action to that inspection this complaint was re evaluated for reportability.
Event or Problem Description
As per initial reporter when using product mdsphy100 , "the clinician followed the instructions when operating the product.The first shock did not deliver and a wrench code was displayed.The clinician unhooked the wires and hooked them back again.At this time, the charge was delivered with no issues." there were no samples of the product returned for evaluation and no serious injury or death was reported.

• Brand Name: MEDLINE MULTI FUNCTION DEBIBRILLATION ELECTRODE
• Common Device Name: RADIOLUCENT DEFIBRILLATION ELECTRODE ADULT/CHILD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• MDR Report Key: 11641818
• Report Number: 1317188-2021-06740
• Device Sequence Number: 14430608
• Product Code: MLN
• UDI-Device Identifier: 10888277635005
• UDI-Public: (01)10888277635005(17)221002(10)Y00219-05
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: MDSPHY100
• Device Catalogue Number: 6600231H
• Device Lot Number: Y00219-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1