MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

Model Number	X SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/16/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) female patient, the device was unable to obtain an ecg signal.Complainant indicated that the crew believed there was a period of time where the electrode pads were not plugged into the defibrillator.After the electrode pads were plugged into the defibrillator, the patient showed asystole.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the returned multi-function cable and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Communication with the customer confirmed that the multi-function cable was not attached to the electrode pads during the event in question.Once the crew identified the pads were not plugged in, they remedied the situation and did not observe a shockable rhythm.The investigation concluded that the device operated as intended.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the returned multi-function cable and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Communication with the customer confirmed that the multi-function cable was not attached to the electrode pads during the event in question.Once the crew identified the pads were not plugged in, they remedied the situation and did not observe a shockable rhythm.The investigation concluded that the device operated as intended.The device was retained at zoll medical and the customer received a replacement device.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6693032
• Report Number: 1220908-2017-01568
• Device Sequence Number: 16455675
• Product Code: MKJ
• UDI-Device Identifier: 00847946006327
• UDI-Public: 00847946006327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2017

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: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 06/19/2017; 06/19/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/04/2017; 08/11/2017
• 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: 20 MO