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

Model Number	MODEL 100
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll autopulse platform was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
As reported, the autopulse platform (b)(4) was displaying user advisory (ua) 02 (compression tracking error) and user advisory (ua) 17 (max motor on time exceeded during active operation) error message.No additional information was provided.No known impact or consequence to patient.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform displayed ua2 (compression tracking error) message was confirmed during the review of the archive but not during functional testing.The reported complaint of ua17 was confirmed during the review of the archive and during functional test.Following service, including replacement of the drive train motor and deburring the clutch plate, the platform passed all testing criteria.Visual inspection was performed and no physical damages were observed.Functional testing was performed and the ua2 error message could not be reproduced.However, the ua17 error message was able to be replicated, thus confirming the reported complaint.The fault was found to be due to the defective drive train motor.Further testing shows that the encoder drive shaft does not rotate smoothly, exhibits binding and resistance; unrelated to the reported complaint.The clutch plate required deburring.A review of the autopulse's archive was performed and it shows ua2 and ua17 error messages occurred on (b)(6) 2018, rather than on the reported event date given by the customer of (b)(6) 2018, thus confirming the reported complaint.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse serial number (b)(4).

• 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: 7329448
• Report Number: 3010617000-2018-00335
• Device Sequence Number: 105643
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 8700-0730-08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1