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); Device Operational Issue (2914)

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

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review but not during functional testing.This indicated that the load sensing system has detected a weight/load imbalance between the two load cells.(ua) 07 indicated that either the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.Additionally, unrelated to the reported complaint, platform failed functional testing due to the user advisory (ua) 08 (motor controller fault detected) error upon powering on the platform, error was cleared after two restart attempts.Furthermore, the autopulse was tested using the 95% patient test fixture (lrtf) and failed with user advisory (ua) 16 (timeout moving to take-up position).The motor controller board was replaced and brake gap was cleaned to remedy these issues.The autopulse platform is a reusable device and was manufactured on 09/30/2014.Therefore, this type of issue is characteristic of normal wear and tear for the life of the device.Visual inspection was performed and found no physical damaged observed upon receipt.The data archive showed multiple user advisory (ua) 07 and user advisory (ua) 08 error messages on the reported event date.After replacing the defective parts, the platform was further tested for 25 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was two similar complaints reported for autopulse platform with serial (b)(4).Ccr (b)(4), reported on (b)(6) 2015 and ccr (b)(4), reported on (b)(6) 2017.The load cells were replaced to address these complaints.

Event Description

As reported during patient use, the platform displayed error message user advisory (ua) 07 (discrepancy between load 1 and load 2).The customer tried to re-position the patient several times; however, same issue persisted.The use of the autopulse was discontinued and manual cpr was performed for an unknown length of time.No further information was provided.No known patient consequences 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7530889
• MDR Text Key: 108858196
• Report Number: 3010617000-2018-00560
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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