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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed through functional testing and archive data review of the autopulse platform ((b)(4)).The platform was functionally tested and during initial take up, displayed a (ua) 16 (timeout moving to take-up position) error message which was attributed to a seized brake gap.The root cause of the ua 16 error message is due to this observed issue.After the brake gap was unseized, the platform was further functionally tested and passed specification.Review of the archive data confirmed the occurrence of multiple user advisory (ua) 16 (timeout moving to take-up position) error messages on (b)(6) 2018.Thus, confirming reported event.As part of routine service during testing, the device was further examined and found a damaged top cover.The autopulse platform is a reusable device and was manufactured on 05 sep 2013.It is approaching its expected service life of 5 years.The device has not seen regular preventive maintenance.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.This observation is not related to the reported event.After replacement of the top cover.The platform was further tested and passed to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial (b)(4).

Event Description

The autopulse platform ((b)(4)) displayed a user advisory (ua) 16 (timeout moving to take-up position) error message.User was unable to clear the ua 16 error message.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7563543
• MDR Text Key: 109888448
• Report Number: 3010617000-2018-00593
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 05/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• 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