MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number R SERIES

Device Problems Self-Activation or Keying (1557); Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 09/25/2022

Event Type  Injury  

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) female patient, while in aed mode, the device self-discharged and delivered energy to the attenting nurse and doctor.The device was switched to manual mode and delivered 3 successful shocks to the patient.Complainant did not indicate that there was any adverse effect to the patient or the two staff members due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation; instead, the device activity log was provided.Review of the device activity log showed the device is powered on in auto defib mode.The device prompted stand clear, shock advised, press shock.The log recorded the shock button was pressed and a shock was delivered.Within a minute, the device is changed to manual mode.The log recorded that the expected advisory prompts occurred, warning the operator to stand clear of the patient.Review of the activity log showed all logged shock events were preceded by a shock button press.The r series devices are to be used by trained personnel.In addition to the advisory and shock prompts, the r series is designed to provide a distinctive charge ready sound and display defib xxxj ready on the screen when it is charged, along with an illuminated shock button and audible shock tone.The user must always press the shock button to deliver the energy.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15559430
• MDR Text Key: 301335516
• Report Number: 1220908-2022-03892
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female