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	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform (sn (b)(4) ) displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during initial functional testing and archive data review.To remedy the issue, the driveshaft was rotated back to the home position.The root cause for the ua45 error message was due to the driveshaft not being at home position, which is likely attributed to user error.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 customer's reported secondary complaint of the autopulse platform displayed user advisory (ua) 12 (lifeband not present) error messages was confirmed during archive data review but not during functional testing.As a precautionary measure, the belt switch assembly was adjusted to a parallel position.The autopulse platform is a reusable device and was manufactured in september 2010, and it is more than 10 years old, well beyond its expected service life of 5 years.During visual inspection, unrelated to the reported complaint, a hairline crack on the front enclosure was observed.This type of physical damage was likely attributed to user mishandling as the front enclosure was last replaced in april 2021.The front enclosure was replaced to address the physical damage.During functional testing, user advisory (ua) 45 (not at "home" position after power-on/restart) error message displayed upon power on the device, thus confirming the reported complaint.The archive data was reviewed and contained multiple user advisory (ua) 45 and one user advisory (ua) 12 error messages around the reported event date, thus confirming the reported complaint.Based on the archive, the advisory (ua) 12 error message was cleared by the customer.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.The autopulse platform passed the final testing without any fault or error.Historical records were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4) ) displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) and user advisory (ua) 12 (lifeband not present) error messages.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: 11867779
• Report Number: 3010617000-2021-00434
• Device Sequence Number: 3401836
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: 04/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1