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

Model Number MODEL 100

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

Patient Problems Bone Fracture(s) (1870); Liver Laceration(s) (1955); Spinal Column Injury (2081)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

The autopulse platform in reported event was returned to zoll on 02-mar-2016 for investigation.A visual inspection of the returned platform was performed and found no visible or physical damage to the platform.A review of the platform's archive data was performed and two user advisories (ua) 17 (max motor on time exceeded) and ua 2 (compression tracking error occurred at first compression) were observed on (b)(6) 2015.A nimh battery sn (b)(4) with high remain capacity (1541) was used on a medium/large patient too stiff to compress.After a few minutes of compression, the device stopped compressing multiple times due to ua 17 - (max motor on time exceeded).The device continued to be used again until it stopped with multiple ua 2 - compression tracking error occurred on the first compression.This typically occurs if the patient is misaligned on the platform or the lifeband is opened.A brake gap inspection was performed and verified that the brake gap was within the specification.Load cell characterization testing was also performed, and confirmed both load cell modules are functioning within the specification.The run_ in test was performed using the 95% patient test fixture (lrtf) for several hours, and did not duplicate any of the user advisory or fault.The autopulse passed all the testing and meets all required specifications.Since the nimh battery s/n (b)(4) involved during the event was not returned for evaluation.The root cause of the user advisory 17 could not be determined.The archive data showed that 1103 cycle compressions were performed by the autopulse for a duration of sixteen (16) minutes on (b)(6) 2015, the date of the reported event.Based on the investigation results, no parts were identified for replacement.In summary, the autopulse platform passed functional testing and met specifications.No device malfunction was found.The reported death was not related to the autopulse device as the device performed as intended.The patient's death is likely to be associated with patient's initial clinical condition.Rib fracture, liver laceration and related physical injury are expected adverse events for both manual and mechanical cprs.According to published reports standard manual cpr complications occur at a rate of 33% for rib fracture, 2.4% for liver laceration and 2.6% for pneumothorax.These rates are comparable to rates with the use of the autopulse.The aha guidelines of 2000 and 2005 stated that "even properly performed chest compressions can cause rib fractures in adult patients", thus "concern for injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".

Event Description

On (b)(6) 2015, the ems crew responded to a (b)(6) female patient described as being heavy built, who was unresponsive, not breathing for 5 minutes prior to ems arrival and having no pulse.There was no bystander cpr performed.There were no signs or symptoms of trauma to the patient.The crew moved the patient and immediately began performing manual cpr on the patient's bathroom floor.The patient was shortly moved to another room where the autopulse was deployed without any issues.During active operation, the autopulse performed compressions successfully, however the crew opted to discontinue its use.There was no device malfunction reported.Zoll was informed that the patient never achieved rosc (return of spontaneous circulation) and expired during transport to the hospital.An autopsy was performed on the patient which revealed broken ribs on both the front and back, a liver laceration as well as a severed lower lumbar spine.No information is available as to the determined cause of death.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood avenue; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5515033
• MDR Text Key: 40829704
• Report Number: 3010617000-2016-00179
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: consumer,health professional
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• 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: 46 YR