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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

The incident occurred on the morning of (b)(6) 2014 at the cath lab with a (b)(6) female patient.The patient was already on the table in the operating room for a cath procedure (specific details were not provided).During the cath procedure, she had a sudden cardiac arrest, which was witnessed by the cardiologist.The staff went to retrieve the autopulse, which was hanging on the wall.While lifting the patient up and trying to place the platform underneath her, the autopulse lifeband fell out of the channel on the back of the platform.The platform displayed a "replace lifeband" message; however, the staff did not replace the lifeband.Use of the autopulse was discontinued and the staff reverted to manual cpr (exact length of time was not provided).No compressions were performed with the autopulse.Patient never achieved return of spontaneous circulation (rosc).The cause of the cardiac arrest and death are unknown.It is unknown if an autopsy was performed.Customer does not attribute the patient's death to the use of the autopulse.

Manufacturer Narrative

After the reported incident, customer replaced the lifeband with another one and realized that the lifeband falls out very easily.It was found that the distance between the black tabs on the platform that hold the lifeband in place was too wide.The autopulse platform in complaint was returned to zoll on 12/02/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection was performed and the customer's reported complaint of the lifeband falling off of the platform's channel die cast assembly was confirmed.During evaluation, a test lifeband was connected to the platform and was found to not lock and clip onto the roller belt as intended.The lifeband was falling off of the channel.Visual inspection of the autopulse platform indicated that the channel in which the lifeband connects onto the autopulse platform was the cause of the issue.Following replacement of the die cast channel, the autopulse platform was functionally evaluated using a large resuscitation test fixture (equivalent to a 250 lb patient).The results of the testing indicated that the loose lifeband issue was resolved and the autopulse platform passed all testing criteria.Load cell characterization testing was also performed and indicated that both load cell modules were functioning as intended.Unrelated to the reported complaint, a sticky encoder shaft was observed during functional testing and was attributed to a damaged clutch plate.The clutch plate was replaced to remedy this issue.There were no user advisories noted on the reported event date of (b)(6) 2014.Based on the investigation, the part identified for replacement was the channel die cast assembly and damaged clutch plate.In summary, the reported complaint was confirmed during visual inspection and attributed to the platform's channel die cast assembly.Following service, including replacement of the die cast channel as well as the damaged cutch plate, the device passed all testing requirements.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4303149
• MDR Text Key: 5269347
• Report Number: 3010617000-2014-00645
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• 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
• Treatment: MANUAL CPR
• Patient Age: 70 YR