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

Model Number R SERIES

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Electric Shock (2554)

Event Date 08/16/2022

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to pace a 45-year-old male patient, the electrodes would not adhere to the patient's skin during compressions.Complainant indicated that the patient subsequently expired.

Event Description

Complainant alleged that while attempting to pace a 45-year-old male patient, the electrodes would not adhere to the patient's skin during compressions.Complainant indicated that the patient subsequently expired.Complainant alleged that during the event while treating the patient, two staff memebers received an unintended delivery of energy while performing cpr.Staff members received first degree burns to the hands and were given silvadene to apply later.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections b5 and h6 (health effect clinical code, medical device problem code, health effect impact code).Evaluation: the device was not returned to zoll medical corporation for evaluation.Instead, the electrode pads used at the time of the report were returned.The customer's report of "will not adhere" was not replicated or confirmed.The pads were stuck together and were unable to be separated without causing damage.The pads had hairs stuck to them.The anterior pad had gel rolled up away from the tin and had a monitoring electrode stuck between the pad and the cpr puck.The posterior pad had a monitoring electrode stuck to the pad as well.The electrode pads passed continuity testing from the tin to the connector pins and the p- leads to the connector pins.The pads were scrapped and the customer was sent a replacement set.The customer's report of "electrical shock to end user" was observed in the customer's returned photograph, which indicates a first-degree burn was obtained while the operators were touching the patient to perform cpr while pacer pulses were being delivered, which the customer agrees is out of the ordinary and not typical practice for them.The reddening is at the base of the palm, suggesting the sliding of the electrodes due to poor coupling contributed.The r series operator's guide instructs, to avoid risk of shock, do not touch the gelled area of the hands-free therapy electrodes while pacing, or touch the patient while delivering energy.The device was not returned for evaluation and no clinical file was available.No trend is associated with reports of this type.

• 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: 15382879
• MDR Text Key: 299547988
• Report Number: 1220908-2022-03344
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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: 08/18/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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): Death
• Patient Age: 45 YR
• Patient Sex: Male