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	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (sn: (b)(4)) was received at zoll (b)(4) for evaluation as per customer's request after the platform was dropped and the top cover was cracked during shift check.During the investigation, the platform failed the initial functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message displayed upon powering up.The root cause for the observed ua07 was due to a defective load cell module 2 as a result of damage sustained by user mishandling.During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization results confirmed load cell module 2 over reported/defected.The load cell module 2 was replaced to remedy the occurrence of ua07 error message.During the visual inspection of the returned platform, the top cover was observed cracked at the lower corner on the patient's right-hand side of the autopulse platform.The root cause was due to user mishandling.The top cover was replaced to remedy the issue.Following service, the autopulse platform passed the final testing without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
The customer requested the autopulse platform (sn: (b)(4)) to be evaluated after the platform was dropped by the staff during shift check.Per customer, the top cover was cracked after the incident.During device evaluation, the autopulse platform failed initial functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9856535
• Report Number: 3010617000-2020-00288
• Device Sequence Number: 3308281
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• 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): 03/19/2020

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1