MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	8900-0221-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Defibrillator pads were not adhering to skin.We removed the set of pads and discovered gel had migrated and congealed in clump to center of pad and silver packing was exposed to patient's bare skin.This had happened on both defibrillator pads on same set.Pads had been placed on the patient prior to patient going to or and the set of defibrillator pads were on the patient for less than 24 hrs.We saw this same defibrillator pad gel clump into one spot on another set of defibrillator pads used for another patient.Two occurrences two different defibrillator pads used on two different patients within 48 hours.Staff did not keep packaging so do not know lot number or expiration dates.Manufacturer response for automated external defibrillators (non-wearable), onestep (per site reporter): unknown at this time.

• Brand Name: ONESTEP
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park dr.; pawticket RI 02861
• MDR Report Key: 7153933
• Report Number: 7153933
• Device Sequence Number: 73091
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: (01)00847946016241
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2017
• Report Date (Section F): 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8900-0221-01
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Patient Age: 71 YR
• Date Report Sent to FDA: 12/27/2017