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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that a system error / out of service / perform manual cpr error message was observed on the autopulse platform (sn (b)(4)) display screen.It was also reported that the platform's metal hooks on the upper housing was broken.The issue occurred during shift check.No patient was involved with this event.No further information was provided.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(4)) displaying a system error message was confirmed during functional testing and archive data review; the root cause was due to a defective processor board.The autopulse platform is a reusable device and was manufactured on 31 mar 2007 and has exceeded its expected service life of 5 years.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the display screen.It was indicated that the processor board was defective.The archive data was reviewed and contained a system error message.As part of routine service during testing, the platform was examined and found physical damages.The observed physical damages were unrelated to the system error message.Upon replacement of the processor board and the damaged components, the platform was further tested including the load characterization check and passed the testing.The platform operated with continuous compression without any issues or further error messages observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).

• 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: 6327833
• Report Number: 3010617000-2017-00119
• Device Sequence Number: 19108992
• Product Code: DRM
• UDI-Device Identifier: 00849111000598
• UDI-Public: 00849111000598
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1