MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of autopulse displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error messages was confirmed during initial functional testing and archive data review.To remedy the issue, the driveshaft was rotated back to home position.The likely root cause of the issue was due to user error.Per the autopulse user guide instruction, to clear (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.During functional testing, user advisory (ua) 45 displayed upon powered on the device, thus confirming the reported complaint.The encoder drive shaft position was not within the normally acceptable range.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, encoder cover was observed damaged and encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The sticky clutch plate was deburred and encoder cover was replaced to remedy the issue.Autopulse platform is a reusable device and was manufactured in 2006.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.The device has exceeded its expected service life of 5 years.Review of the archive data indicated user advisory (ua) 45 error messages were recorded on the reported event date.The autopulse was subjected to 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.Historical complaints were reviewed for service information related to the reported complaint and there were two similar complaints reported for autopulse platform sn (b)(4).Ccr (b)(4) reported on (b)(6) 2013, and ccr (b)(4), reported on (b)(6) 2016.The driveshaft was moved to the home position to remedy the issue for both of these complaints.
Event or Problem Description
As reported, the autopulse platform (sn (b)(4)) displayed a user advisory - ua 45 (driveshaft not at "home" position after power-on/restart) error message on the screen panel.No known impact or consequence to the patient.No additional information provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7886760
• Report Number: 3010617000-2018-00949
• Device Sequence Number: 19345221
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/18/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1