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

Model Number	MODEL 100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on 06/06/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.The rib fracture and large haemopeirtoneum caused by a hepatic sore are not related with the use of the autopulse device.The manager of the users confirmed that the rib fracture was due to the primary manual cpr performed by the junior rescue team that was not correctly trained.Rib fracture, liver lacerations, and hemothorax are expected adverse event for both manual and mechanical cprs.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Even though rib fracture is an expected ae for mechanical cpr, in this case, the user confirmed that the primary cpr was performed manually by untrained junior rescuer, and manual cpr caused the fracture.Evaluation has not been completed.
Event or Problem Description
It was reported that on (b)(6) 2016, a (b)(6) woman, was being seen in the emergency room for thoracic pain.It is unknown if manual cpr was performed by a bystander prior to the rescue team arriving.Manual cpr was performed by the rescue team.It is unknown how long manual cpr was performed.In the emergency room (er), the patient went into cardiac arrest for vf (ventricular fibrillation) with acute coronary syndrome.The er staff began resuscitation on the patient using an iot (inductive output tube), mce (medical care evaluator) and the autopulse platform.It was reported that the rescue team who brought the patient into the hospital, performed manual cpr and cpr with the autopulse platform during this resuscitation (length of time is unknown).The patient achieved rosc (return of spontaneous circulation) once.When the patient was being transported to the coronarography room (to perform a coronary angiography), she had a second cardiac arrest.The patient was being transferred for ecmo (extracorporeal membrane oxygenation) for set up.The patient was being prepped in the right femoral artery for a coronary angiography, angioplasty and stent on iva (intraoperative vascular angiography).On (b)(6) 2016 the patient was treated with a venal needle mobilization, which had a bad flow.The patient showed a persisted hemodynamic instability and hemorrhaging.A thoracic-abdominal scanner revealed a right 5th rib fractured and a large hemoperitoneum caused by a hepatic sore.There was no device malfunction reported.It was reported by the manager of the rescue team using the autopulse, that they were a "junior rescue team" and not correctly trained.Their manager also confirmed that the rib fracture was due to the primary manual cpr performed by the rescue team.
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) in complaint was evaluated by zoll on 06/06/2016.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).During the external visual inspection, no physical external damage found.A review of the archive data showed multiple user advisory (ua) 42 (force overload tripped) occurred.This ua indicated the device was applying too much force for the actual size of the patient, therefore it stopped compressions.The user advisories are designed into the platform to "alert" the user that, in this case, the device was compressing over what it should.This prevents the device from delivering the wrong amount of force when performing compressions.The user pressed restart to clear the ua 42 and continue to use the device.The device delivered 508 compressions for six minutes and twenty two seconds, the device stopped compressions, this time due to a ua 7 (discrepancy between load-1 and load-2 too large).This is another built in "alert" to inform the user that the load sensing system had detected a weight/load imbalance between the two load cells.Both of the uas occurred during the process of the device measuring the patient to detect the weight.At which this time the device had a "zero" value, indicating there was "no" patient on the platform.Therefore the device did not restart compressions.The device passed functional testing without any faults or errors.Based on the reported complaint, there was no device malfunction.Upon further investigation of the device it was detected that load cell 2 was slightly lower than specifications.Also during investigation the platform repeatedly stopped compressions due to ua 27 (encoder fault) which is unrelated to the reported complaint.However, this did indicate the encoder needed to be replaced to remedy the ua 27.To remedy ua 7, load cell 2 module and processor board were replaced.The autopulse platform pass all final functional testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5728051
• Report Number: 3010617000-2016-00404
• Device Sequence Number: 49270
• Product Code: DRM
• UDI-Device Identifier: 00849111000550
• UDI-Public: 00849111000550
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR