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

Model Number R SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, defib testing, ecg testing, pace testing and an impedance check without duplicating any malfunction.An internal inspection found no discrepancies.The device was recertified and returned to the customer.Review of the device activity logs showed that a bradycardia rhythm was present even after the device was changed to pacer mode.The configuration used during pacing could not be determined.Instances of ecg lead off were observed in the logs when the user swiched to pacer mode.This suggests that the ecg cable or the one step pacing ecg electrodes were not properly connected on either the device or the patient end.The device was determined to be fully capable of delivery therapy.The multi-function cable, ecg accessory cable, or event electrodes were not returned as part of the investigation.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: 9312379
• MDR Text Key: 166122667
• Report Number: 1220908-2019-03508
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946016173
• UDI-Public: 00847946016173
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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: 70 YR