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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Apnea (1720); Death (1802); Dyspnea (1816); Loss Of Pulse (2562)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2015, crews from (b)(6) department responded to a difficulty breathing call.The patient was a (b)(6) year old male, weighing approximately (b)(6).The patient was found pulseless and apneic, on the floor of a conference room, in an office building where he worked.There was no bystander cpr being performed.The patient's medical history, medication and allergies were unknown to those on scene.The autopulse was deployed without issues and ran for approximately 3 minutes before it stopped, and displayed a user advisory 45 (not at "home" position after power-on/restart) message.Attempts to restart the autopulse platform were successful, although the device only ran briefly before stopping again.The crews reverted to manual cpr (exact length of time was not provided).During the course of the call, the patient was defibrillated several times and an advanced airway (ett) was successfully placed.The patient was extricated using a backboard and was transported approximately 5-7 minutes to the nearest emergency room (er).The patient was pronounced by the er physician.(return of spontaneous circulation) rosc was never achieved.It is unknown if an autopsy was performed, however manufacturer has requested a copy if one is available.Medics stated that the patient's death was not due to the autopulse malfunction, however exact cause of death is unknown.No further details were provided.

Manufacturer Narrative

Customer tried to troubleshoot the reported user advisory (ua) 45 (not at "home" position after power-on/restart) while on the phone with zoll tech.Support rep.On (b)(6) 2015.Zoll tech.Support rep.Walked the customer through installing a new lifeband, however the platform then displayed a ua 12 (lifeband not present) message that was unable to be cleared after re-installing the new lifeband.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)) was returned to the manufacturer for evaluation.Visual inspection was performed and no damages were observed.The platform was run with a large resuscitation test fixture (equivalent to a 250 lb.Patient) for several hours with no user advisories or warnings occurring.The platform performed as intended during functional testing.The archive was reviewed and consistent with the reported information, the data shows that the platform ran continuously for 3 minutes before it stopped and displayed a user advisory 45 code (not at "home" position after power-on/re-start).After the initial stoppage, the data also showed that multiple ua 45 codes recurred.The reported complaint also stated that while the customer was being instructed on how to install the lifeband; the platform displayed a user advisory 12 (lifeband not present).Consistent with this information, the archive showed multiple ua 12 codes occurring on the reported event date of (b)(6) 2015.Unrelated to the reported complaint information, multiple ua 2 (compression tracking error) and ua 7 (discrepancy between load 1 and load 2 too large) codes were also seen on this date.No mechanical issues were identified with the platform that may have caused or contributed to the observed ua codes in the archive.Based on the archive review, the cause of the ua45 codes appears to have been that the lifeband straps were not pulled out completely prior to turning the device on.Ua 12 codes can occur as a result of the lifeband belt clip not being detected by the platform's spool shaft.The screws of the lifeband clip reset switch which hold the lever parallel to the switch case were inspected and found to have been torqued to specification.The clip reset switch was also tested and verified to be closing properly.As no contributory device problem was identified during evaluation, the likely cause of the ua 12 is improper or incomplete installation of the lifeband onto the platform by the customer.Ua 2 and ua 7 codes can occur as a result of misalignment of the patient on the platform during compressions and/or defective load cells or load cell connections.Load cell characterization was performed which showed that both load cell modules were performing within specification.As no contributory device problem was identified during evaluation, the likely cause of the ua 2 and ua 7 codes was misalignment of the patient on the platform during compressions.No parts were identified for replacement during the course of service and evaluation.In summary, the reported complaint of the platform running continuously for 3 minutes before stopping and displaying a user advisory 45 code was confirmed during archive review.The ua 12 code reported to have occurred while the customer was attempting to install a lifeband was also confirmed through archive review.Aside from the reported information, ua 2 and ua 7 codes were also seen on the reported event date.No mechanical issues were identified during device inspection that may have caused or contributed to the observed ua codes or the reported compression stoppage.Based on the full evaluation of the platform, there is no indication that there is a causal relationship between the autopulse platform and the patient outcome.Following service, the device met all final test criteria.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4561167
• MDR Text Key: 5475758
• Report Number: 3010617000-2015-00131
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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 Age: 67 YR
• Patient Weight: 181