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 Problem Cardiac Arrest (1762)

Event Date 05/09/2015

Event Type  malfunction  

Event Description

It was reported that a cardiac arrest occurred on (b)(6) 2015.After 15 minutes of manual cpr, the patient was placed on the autopulse platform for transport to the hospital.Customer reported that the autopulse performed compressions for 5 minutes as the patient was being taken down from the second floor to the ambulance.When the patient was put into the ambulance, the platform stopped performing compressions and displayed a "pull up on lifeband and press restart" message.The customer pulled up on the lifeband and pressed "restart"; however, the same message displayed.Customer then decided to discontinue use of the autopulse and reverted back to manual cpr (exact length of time not provided).No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2015 for investigation.Investigation results as follows: visual inspection was performed and no damages were observed.Functional testing was performed and no issues were observed.The platform ran for 30 minutes with a test manikin and an additional 15 minutes with a large resuscitation test fixture with no user advisories, system errors or warnings exhibited.Load cell characterization was also performed which showed that both load cells are functioning within specification.A review of the platform's archive data was performed.Consistent with the reported information received from the customer, the archive shows that the platform was used on (b)(6) 2015 to perform a total of 571 compressions.Two user advisory (ua) 7 codes (discrepancy between load 1 and load 2 too large) were observed on this day while the platform was powered on by the customer.There were no device deficiencies observed with the platform that may have caused or contributed to the ua 7 codes.Specifically, load cell characterization showed that both load cells are functioning normally.The ua 7 codes likely occurred as a result of patient misalignment/movement on the platform.Based on the investigation, there were no parts identified for replacement.In summary, the reported complaint of the platform displaying a user advisory could not be duplicated during functional evaluation.However, the platform archive data did confirm that the platform was used on (b)(6) 2015 to perform 571 compressions and exhibited two ua 7 codes on this date.The ua 7 codes likely occurred as a result of patient misalignment/movement on the platform.Following service, the device passed all testing criteria.

• 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: 4836410
• MDR Text Key: 5939605
• Report Number: 3010617000-2015-00326
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/19/2015

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: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2008
• 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