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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Liver Laceration(s) (1955); Injury (2348)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

There were no device deficiencies found during evaluation of the returned autopulse platform that could contributed to the reported injury.Review of the archive data indicated the autopulse platform was powered on but failed to initiate compression due to user advisory (ua) 02 (compression tracking error).As the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.The archive revealed the size of the patient/object is too small and light in weight during the take-up.A few minutes later, the user tried to start another take-up but failed due to user advisory (ua) 18 (max take-up revolutions exceeded).During take-up, the drive shaft moved the lifeband past the maximum allowable take-up depth without detecting a patient.Based on the archive review, there were no compressions performed by the autopulse platform during the use on (b)(6) 2019.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The user advisory (ua) 02 error message alerts the operator as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.This typically occurs if the patient is misaligned on the platform or the lifeband is opened or in the incorrect position during take-up/compression.The user advisory (ua) 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.The load characterization check was performed and verified that both of the load cells are within specification.Visual inspection was performed and found a damaged load plate cover, and an encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported issue.To remedy the damage, load plate cover was replaced.The sticky clutch plate needs deburring to address the encoder drive shaft issue.The autopulse platform is a reusable device and was manufactured in october 2012 and is more than 6 years old.It has exceeded its expected service life of 5 years.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.The autopulse was subjected to the run-in test for twice in continuous mode and 30:2 mode using the normal manikin with good known test batteries for 30 minutes without any fault or error.The autopulse was subjected to the run-in test for twice in continuous mode and 30:2 mode twice using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 30 minutes and 25 minutes without any fault or error.Upon customer approval, the components will be replaced and the device will be further tested to full specification.Medical safety assessment: based on the investigation results and archive data review, the patient outcome is not related due to there were no compressions performed by the autopulse platform during the use.

Event Description

During the call, the autopulse platform was used on a (b)(6) years old male patient ((b)(6) kg) in cardiac arrest.Per the reporter, the patient had a medical history of type 2 diabetes, htn and asthma.The cardiac arrest was witnessed by the family member on (b)(6) 2019 at 18:56 pm.Immediate bystander cpr was performed for a duration of 3 minutes prior to the ambulance arrival.The manual cpr was continued by the first responder for a duration of 70 minutes during the transport to the hospital with intermittent rosc.Upon arrival at the hospital, the autopusle platform was used on the patient for one cycle, from 19:59 pm with rosc achieved at 20:01 pm.No device malfunction was observed during the use.The hospital performed the ct scan after rosc and grade 2/3 laceration covering segment 3 & 4 of the liver was noted with no active bleeding.The patient was pronounced dead later in the hospital on (b)(6) 2019 at 00:45 am.The cause of the patient's death was hypoxic brain damage from the arrest.Per medical examiner, the cause of cardiac arrest is unknown, however, the patient had a bilateral chest infection and a bowel obstruction/perf but unknown if these caused the initial arrest.According to the reporter, the patient's death was not attributed to the device.

• 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: 8903968
• MDR Text Key: 154689745
• Report Number: 3010617000-2019-00687
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2012
• 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 Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 98