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	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a user advisory - "(ua) 45" (not at "home" position after power-on/restart) error message on the autopulse platform (serial #(b)(4)) was confirmed during functional testing and during archive data review.The investigation findings revealed of the encoder drive shaft was not within the normally acceptable range.Therefore, the root cause of (ua) 45 was due to the driveshaft not to be at the "home" position in which was likely attributed to user error.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on.A user advisory - (ua) 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Unrelated to the reported complaint, a damaged load plate cover on the ap platform was observed during visual inspection.This type of damage on the ap platform can occur due to normal wear and tear.The damaged part was replaced.The autopulse platform was manufactured in june 2007 and it is 12 years old, well beyond its expected serviceable life of 5 years.During archive data review, multiple errors (ua) 45 identified on the date the event occurred.Thus, confirming the reported complaint.Initial functional testing could not be performed due to ua 45 (not at "home" position after power-on/restart) displayed upon platform power on.To remedy ua45, the driveshaft was rotated back to "home" position by using the administrative menu.During re-evaluation, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The ap platform passed all functional tests and approved for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua) 45" (driveshaft not at "home" position after power-on/restart) message during power on.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: 8834308
• Report Number: 3010617000-2019-00629
• Device Sequence Number: 2587243
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/26/2019

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: 8700-0700-02-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1