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 Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported during patient use in route to the hospital via a helicopter, after a few minutes of compressions the autopulse stopped and displayed "system error, out of service, revert to manual cpr "error message.According to the customer, they tried changing the battery and reset the lifeband however the error message could not be cleared.According to the customer manual cpr was performed for an unknown length of time.The patient outcome was not reported, no harm or patient consequences were provided.No further information was reported.

• 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: 6790403
• Report Number: 3010617000-2017-00653
• Device Sequence Number: 138489
• Product Code: DRM
• UDI-Device Identifier: 00849111000253
• UDI-Public: 00849111000253
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 08/11/2017

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: 8700-0700-22
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1