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

Model Number	R SERIES
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed an "ecg disabled" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer's report was observed and attributed to a faulty shield top shield on the analog board.The analog board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.Instead, a photograph of the reported error message was provided.Review of the photograph confirmed the report; however without receipt of the device or data log file, root cause analysis cannot be performed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11812794
• Report Number: 1220908-2021-01441
• Device Sequence Number: 1266432
• Product Code: MKJ
• UDI-Device Identifier: 00847946017293
• UDI-Public: 00847946017293
• Combination Product (Y/N): N
• PMA/510(K) Number: K060559/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2021

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
• Operator of Device: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 04/21/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/08/2021; 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1