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 Information (3190)

Event Date 11/29/2017

Event Type  malfunction  

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 treat a patient (age & gender unknown),the device was unable to obtain an ecg signal via electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The reported malfunction was observed during review of the activity logs.However, the reported problem could not be duplicated.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs did show several check pads and lead off messages.However, these messages are intended to alert the user that a patient impedance is not recognized and not necessarily indicative of a device malfunction.These messages could mean poor coupling of the electrode pads to the patient's skin, faulty pads or a faulty multi-function cable.The electrode pads and the multi-function cable were not returned as part of this investigation.The customer did confirm that the electrodes were used with another device and worked fine.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: 7131772
• MDR Text Key: 95338056
• Report Number: 1220908-2017-03197
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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