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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020, during preventive maintenance, the autopulse platform (serial#: (b)(4)) failed the load cell characterization test, load cell module 2 was over reported (defective).The root cause of the defective load cell module 2 and cracked front enclosure were likely attributed to mishandling such as a drop.Upon visual inspection, unrelated to the reported complaint, observed cracked front enclosure, missing patient head restraint and a bent battery lock were likely due to user mishandling.The front enclosure, patient head restraint and battery lock will be replaced to address these issues.The initial functional testing of the autopulse platform passed without any fault or error.During further testing, stiff manual rotation of the driveshaft was observed, likely attributed to wear and tear.The driveshaft clutch area needs to be deburred to address this issue.The autopulse platform was manufactured in december 2009, and is 11 years old, well past it's service life of 5 years.Waiting for customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
On (b)(6) 2020, during preventive maintenance, the autopulse platform (serial#: (b)(4)) failed the load cell characterization test, load cell module 2 was over reported (defective).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: 10939821
• Report Number: 3010617000-2020-01264
• Device Sequence Number: 791650
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/02/2020

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1