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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The loaner autopulse platform (sn (b)(4)) was returned from the customer for service.During service on (b)(6) 2021, the load cell module 1 reading was not visible on ap vision software indicating that the load cell module 1 is defective.The damaged cover and defective load cell were likely attributed to mishandling such as a drop.The load cell module 1 was replaced to remedy the fault.Upon visual inspection, noticed damaged bottom enclosure, likely caused by mishandling such as a drop.The damaged bottom enclosure was replaced to address the observed physical damage.The platform failed the initial functional test with user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message.To remedy the issue, the driveshaft was rotated back to the home position.Per the autopulse user guide instruction, to clear user advisory (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.The archive data review showed the presence of the user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) and user advisory (ua) 02 (compression tracking error) error messages as a result of the defective load cell module.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.A load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform passed the final testing without any fault or error.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 number (b)(4).
Event or Problem Description
During service on (b)(6) 2021, the returned loaner autopulse platform (sn (b)(4)) failed the load cell characterization check.No patient involvement.

• 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: 11782112
• Report Number: 3010617000-2021-00385
• Device Sequence Number: 3659296
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1