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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed through functional testing and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to a defective load cell.Upon visual inspection damaged top, front, battery compartment screw bosses and bottom cover were observed.The drive shaft was exhibiting binding and resistance.These observations were not related to the reported event.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.After replacement of the load cell, top cover, front cover, bottom cover, battery compartment screw bosses and deburring of the clutch; the platform passed all testing specifications with no further issue observed.The autopulse platform is a reusable device and was manufactured on 31 jul 2008.It has exceeded its expected service life of 5 years.The platform is 10 years old and has not seen regular preventive maintenance.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
During device check, the autopulse platform displayed error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).No patient was involved.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8011384
• Report Number: 3010617000-2018-01044
• Device Sequence Number: 1464507
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1