MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed through evaluation and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to a defective load cell.Evaluation of the platform during initial power up, revealed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message on the user control panel.The archive data was reviewed and contained multiple ua 7 error message on the reported event.A load characterization check was performed and identified a defective load cell.As part of routine service during testing, the device was examined and found a damaged short black cover and is not related to the reported event.After replacement of the load cell and the short black cover, the platform was further functionally tested to full specification and operated as intended with no further issues observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7605455
• Report Number: 3010617000-2018-00652
• Device Sequence Number: 283522
• Product Code: DRM
• UDI-Device Identifier: 00849111001021
• UDI-Public: 00849111001021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1