Model Number MSERIES BI-PHASIC |
Device Problem
Unable to Obtain Readings (1516)
|
Patient Problem
Death (1802)
|
Event Date 02/15/2019 |
Event Type
Death
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Event Description
|
Complainant alleged that while attempting to defibrillate a (b)(6) year-old male patient, the device displayed a "defib pad short" message.Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient and received the same error.Complainant indicated that the patient subsequently expired.Please reference medwatch report 1220908-2019-00648 for the another defibrillator used in the event.
|
|
Manufacturer Narrative
|
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the complainant was contacted for return of the device.The customer has responded and indicated the device is working fine and the will not be returning to zoll.
|
|
Manufacturer Narrative
|
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing which included bench handling, multiple 30 joules self-tests, shock testing at various joules settings utilizing the returned multifunction cable and continuity testing without duplicating the reported malfunction.The device's biphasic cable was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.Please refer to the attached user medwatch report that zoll medical has received.
|
|
Manufacturer Narrative
|
Additional information: inadvertently did not attach user medwatch report.
|
|
Search Alerts/Recalls
|