MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES

Model Number	E SERIES
Medical Device Problem Code	Improper Alarm (2951)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged a routine shift check by a clinician, the device displayed a "defib pad short" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During disassembly of the device to determine root cause, the technician found that the screws used to install the soft case bracket were the incorrect screws.The screws the customer used were too long which penetrated the lower housing and pierced a hole in a system interconnection cable.The system interconnection cable and lower housing were replaced.This report has been attributed to user mis-handling.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: E SERIES
• Common Device Name: E SERIES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6632016
• Report Number: 1220908-2017-01330
• Device Sequence Number: 13779497
• Product Code: MKJ
• UDI-Device Identifier: 00847946009717
• UDI-Public: 00847946009717
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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
• Operator of Device: Other
• Device Model Number: E SERIES
• Device Catalogue Number: E SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1