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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn (b)(4)) stopped after performing three compressions" was confirmed during the archive data review but not during the functional testing.There were no device malfunction observed during the evaluation and the platform worked as intended.Upon visual inspection, no physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Based on the archive data review, the autopulse platform stopped after performing 2 to 3 compressions due to ua19 error message around the reported complaint date.The archive data showed that the autopulse platform was used on a heavy object (max load sum exceeded 800 lbs).The load plate detected too much weight being applied exceeds 270 lbs/123 kg.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Ua19 error message alerts the operator that the load plate has detected too much weight being applied.The ua19 error message can be cleared by restarting the platform.Upon customer approval, the autopulse platform will be further tested to full specification.
Event or Problem Description
The autopulse platform (sn (b)(4)) stopped after performing three compressions.No additional information was provided.No known impact or consequence to patient information was provided.

• 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: 9172456
• Report Number: 3010617000-2019-00884
• Device Sequence Number: 11397431
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1