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	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the platform is returned and investigation has been completed.
Event or Problem Description
During biomed testing, the auto-pulse platform (sn 40657) displayed user advisory (ua) 12 (life-band not present) error message.The user was unable to clear the ua 12 error message.No patient involvement.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(6) ) displayed user advisory (ua) 12 (lifeband not detected) error message was confirmed during archive data review; however not confirmed during functional testing.No device malfunction observed during the testing that would cause ua 12 error message.The probable root cause for the reported complaint could be due to the belt clip not detected in spool shaft and/or not fully inserted when the autopulse was powered on, most likely attributed to user error.During visual inspection, the platform was observed the head restraints was missing.The head restraint could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints missing head restraints does not render the autopulse platform non-functional.In addition, front enclosure had cracks, torn load plate cover and missing screw.The root cause for the crack on the enclosure and torn load plate cover are due user mishandling such as a drop.These observations are not related to the reported event.The top cover, front enclosure, load plate cover and the missing screw were required to be replaced to address the observed physical damages.During initial functional testing, no issues or error occurred.Noticed that the lifeband detect switch was in correct position and screws were at correct torque.However, during the load cell characterization test revealed that the load cell 2 is defective.The cracked cover and defective load cell were likely attributed to mishandling such as a drop.This is observation is not related to the reported complaint.During archive data review, multiple ua 12 error messages was observed.Per the autopulse® resuscitation system model 100 user guide, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Waiting for customer's approval for service.

• 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: 10709041
• Report Number: 3010617000-2020-01034
• Device Sequence Number: 17014825
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1