MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number AED PRO

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

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 45-year-old male patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the clinical data file of the customer's report was provided.The analysis algorithm incorporated in zoll defibrillators works by taking a nine second ecg sample and dividing the sample into three, 3 second segments.The algorithm then makes calculations based on ten waveform characteristics for each segment.A minimum of two of the three segments need to be identified as ?shockable? in order to have a result of shock advised.Review of the clinical data file concluded the device worked as designed and within the limitations of the technology.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PRO
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16021675
• MDR Text Key: 305873660
• Report Number: 1220908-2022-04964
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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
• Patient Age: 45 YR
• Patient Sex: Male