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

Model Number	X SERIES
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that the during a routine shift check by a clinician, the device displayed a "defib disabled" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical singapore for evaluation; the device's activity log was forwarded to zoll medical us.Review of the device's activity log does show occurrences of a defib failure prompt.The defib board was replaced as a precaution and will be forwarded to zoll medical us for further evaluation.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The processor/bridge/pace board was returned to zoll medical us; the malfunction was duplicated and attributed to a faulty relay on the processor/bridge/pace.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7864026
• Report Number: 1220908-2018-02596
• Device Sequence Number: 1988603
• Product Code: MKJ
• UDI-Device Identifier: 00847946018962
• UDI-Public: 00847946018962
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K112432/P160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2018

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 08/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/05/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1