MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number R SERIES ALS

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Cardiac Arrest (1762); Electric Shock (2554)

Event Date 09/25/2020

Event Type  Injury  

Event Description

The patient was noted to have an acute change in mental status and new left-sided weakness.Code stroke initiated, patient connected to zoll r series defibrillator with pads for continuous monitoring.The patient was transported to ct (computed tomography) with the defibrillator.The patient returned to the room following cta (computed tomography angiography) and the defibrillator was plugged into the wall.The monitor screen of the defibrillator began flashing a battery fault message although the device was plugged into an electrical outlet.The defibrillator was unplugged and plugged into a different electrical outlet, the battery fault message continued.Troubleshooting continued by activating a defibrillator check and the patient was inadvertently shocked with 35.8 joules.The patient suffered a cardiac arrest as a result of the shock.Cpr was immediately initiated.The patient was intubated and there was return of circulation after three rounds of cpr.The patient was transferred to icu.Suggest the manufacturer update equipment to advise the operator if a shock is not advised based on the rhythms.Manufacturer response for defibrillator, zoll r series defibrillator (per site reporter).Zoll replaced the internal battery, ecg isolator, ecg shields, and lcd cable.The device passed all final system-level tests.

• Brand Name: R SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11265312
• MDR Text Key: 229866195
• Report Number: 11265312
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: R SERIES ALS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 32485 DA