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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
As reported during shift check, the autopulse platform ((b)(4)) was displaying error message user advisory (ua) 12 (lifeband not present) and user advisory (ua) 45 (not at "home" position after power-on/restart).The field service technician tried to clear the error by power cycling the platform several times and replacing the lifebands; however, the user advisory (ua) 12 error message persisted.According to the technician, the main shaft does not rotate smoothly.No patient involvement on this issue.
Additional Manufacturer Narrative
The customer reported complaint for the platform displayed a user advisory (ua) 12 (lifeband not present) and user advisory (ua) 45 (not at "home" position after power-on/restart) error messages was confirmed during functional testing and archive data review.To resolve the issue, the belt clip switch assembly was adjusted to a parallel position.Visual inspection was performed and found damaged top cover, unrelated to the reported complaint.Following the replacement of top cover, the device was further tested and passed all testing criteria with no issues or faults observed.During functional testing, the lifeband clip detect switch inspection shows that the switch lever was not able to close and not parallel to the switch case resulting in (ua) 12 and (ua) 45 as expected, and confirming customer complaint of difficult to rotate the drive shaft.After readjustment of the switch lever and verification using a standard belt test clip aid, the platform was further tested and operated as intended without any further issue fault or error.The archive data was reviewed and contained (ua) 12 and (ua) 45 error messages on the reported event date.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with 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: 7457068
• Report Number: 3010617000-2018-00475
• Device Sequence Number: 16553348
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 05/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1