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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event was reproduced during evaluation of the autopulse platform (sn (b)(4)).Functional testing found that the lifeband would not stay on the latch.A lifeband clip detect switch inspection was performed which indicated that the belt clip is damaged and does not stay locked in place.This confirms the reported event.As part of routine service during testing, the device was examined and found a damaged top cover.This is unrelated to the reported event.Upon customer approval, the components will be replaced and the device will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

The user was unable to properly install the lifeband in the autopulse platform (sn (b)(4)).Per report, the lifeband falls off the platform.No notable damage was observed on the platform specifically around the driveshaft slot.The issue occurred during shift check, no patient was involved.This references the issue with the platform.The report of the lifeband unable to be properly installed in the platform is referenced under mfr 3010617000-2017-01151.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7155791
• MDR Text Key: 96124142
• Report Number: 3010617000-2017-01200
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2017

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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