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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2018

Event Type  malfunction  

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 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.

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
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7457068
• MDR Text Key: 106629089
• Report Number: 3010617000-2018-00475
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1