MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY R2 PAD:PCQC DC;ADULT NON-RTL; R2 DEFIB PADS

Model Number	3112-1731
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned by the user facility and no lot samples were available; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A two-year review of complaint history revealed 3 other similar complaints for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure, if all complaints were confirmed.The instructions for use advises the user of the following.Misuse of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.Make sure the skin is dry.I.E.Free of water, sweat, alcohol, etc.If the electrodes do not adhere properly to the patient, apply a new pair.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The user facility initially reported this incident as a "connection error message" and no patient injury was reported.Conmed received a complaint report from the supplier, it was found that the reported 3112-1731 pad would not work during a code and would not give a reading.The patient expired.Upon gathering additional information, the initial presentation of the patient was pulseless and apneic.The reported pads were connected to a lifepack which displayed connection error; rhythm would intermittently display asystole.Defibrillation was not prompted when a rhythm was displayed, and defibrillation was not attempted with the reported pads.The first responders proceeded with cpr and pronounced the patient on the field.This report is being raised on the basis of a reported death of a patient.

• Brand Name: R2 PAD:PCQC DC;ADULT NON-RTL
• Common Device Name: R2 DEFIB PADS
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua CP 11 36; MX CP 1136
• MDR Report Key: 7622045
• Report Number: 3007305485-2018-00133
• Device Sequence Number: 16676648
• Product Code: LDD
• UDI-Device Identifier: 00653405058086
• UDI-Public: (01)00653405058086(17)180624(30)1(10)201606244
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K964469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2018
• Device Model Number: 3112-1731
• Device Catalogue Number: 3112-1731
• Device Lot Number: 201606244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 44 YR