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 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) and user advisory (ua) 42 (force overload tripped) error messages occurring on (b)(6) 2017 was confirmed through archive data review.The returned platform was evaluated and during initial power up displayed a ua 7 error message.The ua 7 and the ua 42 error message are related and the root cause is attributed to a defective load cell.As part of routine service during testing, the platform was examined and found physical damage.This observed issue is unrelated to the ua 7 and ua 42 error message.Upon replacement of the load cell and the damaged part, 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 previous complaint reported for autopulse platform with serial number (b)(4).

Event Description

The autopulse platform (sn (b)(4)) was used during a call and displayed user advisory (ua) 42 (force overload tripped) and ua 7 (discrepancy between load 1 and load 2 too large) error messages.Following this manual cpr was immediately administered on the patient.No known impact or patient consequence was reported.It was further reported that the user tested the platform at the station and was only able to reproduce the ua 7 error message.No further information was provided.

• 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: 7153335
• MDR Text Key: 96121011
• Report Number: 3010617000-2017-01105
• 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: 12/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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
• Patient Age: 50 YR