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

Model Number MODEL 100

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Loss of consciousness (2418); Palpitations (2467); Loss Of Pulse (2562)

Event Date 01/16/2015

Event Type  Injury  

Event Description

The initial call was for a male patient that was in a ventricular fibrillation and pulseless electrical activity (pea) state.The incident occurred at the patient's home.The arrest was witnessed by the patient's wife.The patient had just eaten his dinner and his wife found him slumped in a chair.The patient had a history of myocardial infarction for which he received a coronary stent some years ago.The patient had no prior history of trauma or falls.Information regarding how long the patient was down was not provided.The ambulance crew arrived at the patient's place of residence and performed manual cpr for a short period (exact length of time not provided), while the paramedic placed the patient onto the autopulse platform.The patient was taken to the hospital.Once at the hospital, the autopulse was not removed and manual cpr was not continued.As the patient was in a continuous pea state, the care team decided to stop both manual and automated cpr.No chest x-rays were performed.The patient was pronounced at the hospital.Upon verification of the patient's death, the physician stated that he had widespread emphysema and his chest was very unstable to even light palpations.The physician also indicated that auscultating the patient's chest produced large volumes of blood to come out through the endotracheal tube and that whilst it is very common for rib fractures to occur during cpr, the trauma caused to the patient's chest was excessive.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/24/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.Rib fracture can be caused by manual cpr as well as with the mechanical cpr.Based on the information that is currently available, the connection of the reported injury to the device can neither be confirmed or ruled out.

Manufacturer Narrative

The autopulse platform in complaint was returned to the manufacturer on 2/27/2015 not 2/24/2015 as indicated on the initial report.The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.The investigation results are summarized as follows: a device history review was performed and the records indicated no abnormalities for the autopulse platform.Visual inspection of the returned platform was performed which showed no physical damage to the platform.On the reported event date of (b)(6) 2015, the archive showed the following user advisory (ua) and faults that occurred over the course of 11 sessions.A session is defined as the timeframe in which the device is powered on to the time the device is powered off.Ua 2 (compression tracking error); ua 17 (max motor on time exceeded during active operation); warning 1 (low battery warning battery); ua 45 (not at "home" position after power-on/restart); ua 12 (lifeband not present).Session 1: the autopulse platform was run with a li-ion battery (s/n (b)(4)) for approximately 31 seconds before the platform exhibited a ua 2 fault.Evaluation of the device showed no mechanical issues which could have caused or contributed to this fault.The cause of the ua 2 message was determined to be either patient misalignment or that the lifeband was opened.Session 2: the customer re-aligned the patient and ran the platform for an additional 7 minutes, at which point, the platform exhibited a ua 17 fault.Evaluation of the device showed no mechanical issues which could have caused or contributed to this fault.The cause of the ua 17 was determined to be that the lifeband was opened during operation.Session 3: the customer continued to use the platform for another 4 minutes after which time, a second ua 17 fault and a warning 1-low battery warning message were exhibited.The platform is designed to display a low battery warning message in order to inform the user that the battery has insufficient power to continue compressions and that it should be replaced.The platform was powered off at this point.The archive showed that this battery was not fully charged at the time of use in the autopulse and therefore, the platform displayed the low battery warning message.Please note that the battery was not returned for evaluation.Session 4: the platform was powered on by the customer followed by a "battery lost" message.This is an indication that the customer removed the li-ion battery (s/n (b)(4)) from the autopulse platform during active operation.In order to swap a battery, the customer is required to power off the platform and then exchange the battery.In this case the customer did not power off the platform before removing the battery.Therefore, as intended, the platform displayed a "battery lost" message.The platform was powered off and li-ion battery (s/n (b)(4)) was exchanged with a fully charged li-ion battery (s/n (b)(4)).Please not that this battery was not returned for evaluation.Session 5-8: upon power up of the device, the platform exhibited a ua 45 fault.The cause of the ua 45 fault was due to the lifeband straps not being pulled out completely prior to turning the platform on.The device was power cycled repeatedly with this ua 45 fault occurring from the fifth session through the eighth session.The reason for the ua 45 recurring is because the customer did not clear the ua before restarting the platform.The customer then successfully cleared the ua 45 fault by pulling up the lifeband completely and continuing to use the autopulse.Session 9: the platform was used for more than 20 minutes until the platform displayed a ua 17.This was a result of the lifeband being opened while performing compressions.Please note the lifeband was not returned for evaluation.The customer did not report any issues with the lifeband.Session 10: the customer continued to use the platform for another 20 minutes and no issues were observed.The customer then stopped compressions.Session 11: upon restarting compressions, the platform exhibited a ua 12 fault.Ua 12 is an indication that the autopulse has detected that the lifeband is not properly installed.At this point, the customer powered off the autopulse platform and discontinued usage of the device.Functional testing was performed.During compression testing, using a 95% patient test fixture (large resuscitation test fixture), the platform performed as intended.In addition, load cell characterization testing was also performed to ensure that both of the platform's load cells are reporting correctly.All parameters for autopulse platform (s/n (b)(4)) met manufacturer's specifications.In summary, the platform was functionally tested and the device performed as intended.To prevent patient harm, the autopulse system is designed to enter a ua or fault state when one of the several conditions is detected.In this case, ua 2 message indicated that a misalignment or inappropriate movement of the patient or the lifeband had occurred during transportation in an ambulance to the hospital.However, after realigning the patient (as shown in session 2), the user did not re-install the lifeband properly as indicated by uas 17, 45, & 12.Improper placement of the lifeband can cause multiple injuries to the patient such as those reported to have happened during this event.However, connection of the reported injury to the device cannot be ruled out.Additionally, rib fracture can be caused by manual cpr as well as with the mechanical cpr.There were no issues identified with the platform during functional and archive evaluations.

Event Description

On february 27, 2015, the clinical supervisor, (b)(6), ensured that the autopulse functioned properly.He did not report any device issues.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4542893
• MDR Text Key: 5544940
• Report Number: 3010617000-2015-00105
• Device Sequence Number: 1
• Product Code: DRM
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2014
• 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 Outcome(s): Other