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

Model Number MODEL 100

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Laceration(s) (1946); Swelling (2091); Injury (2348); Loss of consciousness (2418); Pallor (2468); Abdominal Distention (2601)

Event Date 05/30/2014

Event Type  Injury  

Event Description

The following information was submitted by the customer on two different user facility medwatch reports and through follow up.Customer received a call regarding a (b)(6) year old male patient, weighing approximately (b)(6) pounds.Co-workers indicated that the patient was at the loading dock of the trucking company, when they found him lying face down on the floor.Co-workers denied that the patient had complained of any pain or shortness in breath and there was no apparent injury from a fall.Coworkers began manual cpr (exact length of time was not provided).A call was dispatched at 10:05 am.(b)(6) fire department were the first to arrive on scene at 10:14 am.(b)(6) fire are a bls (basic life support) crew.Fire department took over manual cpr upon their arrival (exact length of time was not provided).When (b)(6) paramedics arrived, the fire department was performing cpr.Cardiac monitor was applied at 10:17 am.The (b)(6) paramedics deployed the autopulse at 10:18 am.The autopulse had to be repositioned after two compressions as the lifeband slid 1 inch from proper positioning.The patient was subsequently intubated and blood was noted in the endotracheal (et) tube.Thick rhonchi upon auscultation.The patient was extricated onto a backboard, then onto a gurney and placed in the ambulance.Initial and tidal co2 was 24.Despite use of the autopulse, the end tidal co2 fell to 4.Bilateral lung fields were reassessed and lung sounds remained unchanged.It was observed that his face and eyes began to swell significantly and turned cyanotic.The patient was transported to the hospital via ambulance at 10:29 am and arrived at the er at approximately 10:44 am.The autopulse was discontinued and manual cpr (exact length of time was not provided) was resumed.The er staff that were performing manual cpr indicated that the patient's chest was concave and "mushy".A large amount of subcutaneous emphysema and distention were noted in the patient's neck and face.The patient expired at 10:58 am.Customer could not provide the cause of the patient's death.Customer indicated that an autopsy was performed and the results have not been provided yet.Initial verbal report from the pathologist at the time of autopsy indicates severe injuries, including a lacerated liver and pulmonary artery.Patient had a history of hypertension, back problems and prostatism.No further information was provided.

Manufacturer Narrative

The pathologist stated to the er physician at (b)(6) that the injuries resembled those of someone who had "jumped off a three story building".According to the paramedics documentation "the autopulse strap was initially applied at approximately 1 inch lower than the desired position.The patient inadvertently developed bilateral rib fractures, bilateral pneumothorax and subcutaneous emphysema resulting from complications of cpr, however, it is unable to be determined whether these complications were caused by manual or automated cpr.Placing the lifeband lower than the desired position can increase the potential for such injuries.Per zoll, labeling instructs the user to center the lifeband on the patient's chest, placing it such that it's center is over the area upon which manual compressions are conducted.Furthermore the labeling warns that failure to properly position the lifeband at the patient's armpit line may cause injury to the patient.In addition, based on the timing provided during follow up conversation, the autopulse successfully provided compressions for approximately 26 minutes (which indicated that the device had performed as intended per manufacturer labeling).Since the device was used for 26 minutes, the battery could have been depleted.Additionally according to 12 different published reports common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) can occur as a result of manual cpr injuries.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) associated with this complaint was not returned for evaluation.The data archive for the ap platform (s/n (b)(4)) was provided for review.In addition, the archives for the mc chargers (s/ns (b)(4) and (b)(4)) used by the customer and li-ion battery (s/n (b)(4)) used at the time of the event, were also provided.The reported information provided by the customer indicates that the injuries observed were lacerated liver, pulmonary artery injury, subcutaneous emphysema, bilateral rib fractures, and bilateral pneumothorax.There were no issues reported with respect to the performance of the autopulse platform or li-ion battery, either prior to or during deployment.It was also reported that the lifeband was applied approximately 1 inch lower than the desired position.Zoll labeling instructs the user to "center the lifeband on the patient's chest, placing it such that its center is over the area upon which manual compressions are conducted." the instructions for use also warns the user that failure to properly position the lifeband at the patients' armpit line may cause injury to the patient.The data archives for the mc chargers and li-ion batteries were reviewed and show no evidence of any device malfunction that could have caused or contributed to the reported injuries.The data archive for the autopulse platform was reviewed and identified the following: the autopulse platform was powered on, performed 6 compressions for 1 minute and then displayed a user advisory 20 (position out of range).Following the occurrence of the ua 20, the platform was then powered off and on again and successfully performed a total of 932 compressions over a duration of approximately 17 minutes.A user advisory 17 (max motor on-time exceeded during active operation) was then observed.After being power cycled again, the platform successfully performed 310 additional compressions for approximately 5 minutes, followed by a user advisory 2 (compression tracking error).The platform was then powered off and on again and two minutes of additional compressions were performed, with another ua 2 fault occurring.Following this advisory, use of the platform was discontinued.Based on the archive review for the autopulse, the platform successfully performed approximately 26 minutes of continuous compressions, which indicates the device performed as intended per the manufacturing labeling.The user advisories observed in the archive are not known to cause or contribute to the reported pattern of injuries.Based solely on archive data and without having the autopulse platform and li-ion battery available for physical evaluation, a definitive cause for the observed user advisories could not be determined.It should be noted however, that the autopulse platform is designed to display these user advisories in order to alert the user to perform specific steps to ensure uninterrupted active operation.Ua 2 (compression tracking error) is an indication of patient movement or uneven distribution of weight on the platform.It is possible that since the autopulse was deployed while the patient was in transit to the er, they may have shifted on the platform while compressions were being performed.Ua 17 (max motor on-time exceeded during active operation) is an indication that the lifeband may have become twisted during use.Ua 20 (position out of range) is an indication that the lifeband was not fully extended prior to it being centered onto the patient's chest.Based on additional information provided indicating that the lifeband was placed 1 inch lower than the desired position, it is likely that the lifeband was not aligned correctly leading or contributing to the ua 2, ua 17 and ua 20 advisories.Liver damage is a known complication for compression of any kind.Because both manual and autopulse cpr were performed in this case, the cause of liver damage is undetermined.Broken ribs, pneumothorax and emphysema injuries are likely with manual cpr as well as with the mechanical cpr.According to 12 different published reports standard manual cpr complications occur at rates of 33% for broken ribs, 2.7% for pneumothorax, and 1.4% for subcutaneous emphysema.Conclusion: in summary, the devices used at the time of this event were not returned to zoll for evaluation.Based on review of the archives for the autopulse platform (s/n (b)(4)), mc chargers (s/ns (b)(4) and (b)(4)), and li-ion battery (s/n (b)(4)), there were no issues identified that could have caused or contributed to the reported injuries including lacerated liver, pulmonary artery injury, subcutaneous emphysema, bilateral rib fractures, and bilateral pneumothorax.The autopulse archive showed that the platform successfully performed 26 minutes of continuous compressions, as intended per the device labelling.User advisories 20, 17, and 2 were observed in the platform archive, however were determined to not have caused or contributed to the injuries reported.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3942611
• MDR Text Key: 18933879
• Report Number: 3003793491-2014-00340
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2010
• 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; CHEST COMPRESSION ASSEMBLY, AUTOPULSE® LIFEBAND
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 62 YR
• Patient Weight: 113