MAUDE Adverse Event Report: CARDIAC SCIENCE CORPORATION POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number G5S-80C

Device Problem Unable to Obtain Readings (1516)

Patient Problem Necrosis (1971)

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received both products and will be providing a supplemental report when our investigations are completed.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), using device sn (b)(4), the device was unable to detect the electrode pads.Complainant indicated that the clinician reapplied the pads with no change.They then attempted a reset of the aed with no change.They obtained another set of electrode pads with no change.The clinician's obtained another device sn (b)(4) that also was unable to detect the electrode pads.The crew performed continuous high quality cpr to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The customer's report was not replicated or confirmed.The device's passed all testing without duplicating any malfunction associated with the customer report.Review of the rescue files for device showed no clinical data being logged.There are no errors that could contribute to the customer's report.The log evidence suggests the device did not recognize a viable patient impedance and as a result could not analyze.The electrode pads used during the event were not returned for investigation.The device was also tested with factory pads to ensure it was recognizing being connected to a viable patient impedance; confirmed to be functioning to specification.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: POWERHEART G5 KIT,SEMI, US EN/LA ESP, CPRD
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): CARDIAC SCIENCE CORPORATION; 500 burdick parkway; deerfield WI 53531 9692
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12516404
• MDR Text Key: 272849621
• Report Number: 2112020-2021-00921
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00812394021307
• UDI-Public: 00812394021307
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: G5S-80C
• Device Catalogue Number: G5S-80C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: POWERHEART G5 KIT,SEMI , SN (B)(6)
• Patient Outcome(s): Death