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

Model Number R SERIES

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Power Up (1476); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 during a routine shift check by a clinician, the device failed to charge and inappropriately shut down.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: the customer's report was observed by a zoll approved service provider during initial testing.The customer's report of the device shuts off intermittently was observed during testing.However, the reported problem could not be duplicated.The ac charger was replaced as a precaution.The device was recertified and returned to the customer.Evaluation of the customer's report for device will not power up with ac was duplicated and attributed to a resistor on the ac charger.The ac charger was replaced to resolve the report.This report was inadvertently submitted and reports of this nature are typically not submitted as there would be no potential for clinical impact.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device inappropriately shut down and would not power up with ac.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Evaluation: the device was returned to a zoll approved service provider.The customer's report of device powered off was observed during testing.However, the reported problem could not be duplicated.The ac charger was replaced as a precaution.The device was recertified and returned to the customer.The customer's report of the device would not power up was duplicated and the ac charger was replaced to resolve the report.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device would not power up and inappropriately shut down.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11101046
• MDR Text Key: 225344873
• Report Number: 1220908-2020-04286
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1