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

Device Problems No Audible Alarm (1019); Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

Patient Problems Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

While preparing patient for cardiac catherization, defibrillator inadvertently delivered 35.3j, putting the patient in vfib.Defibrillator appears to have been at a low or depleted battery duration of the case.Clinical team was unaware of the lack of connection to ac power.Defibrillator appears to have turned off during the case several times.Once clinical team became aware of vfib, responded and recovered patient to normal sinus rhythm.During investigation, concerns were raised regarding appropriate low battery alarms and audible charging tones.

• 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: 15248700
• MDR Text Key: 298130770
• Report Number: 15248700
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2022
• Device Age: 3 YR
• Date Report to Manufacturer: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Sex: Female
• Patient Weight: 37 KG