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

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Dyspnea (1816); Loss of consciousness (2418)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

A (b)(6) year old male patient weighing approximately (b)(6) ibs, was found unconscious and unresponsive at his place of residence.It is unknown how long the patient was down.A family member dialed 911 and upon (b)(6) fire department arrival, the patient was found unresponsive and not breathing.A family member began manual cpr (length of time is unknown).(b)(6) fire department initiated manual cpr (exact length of time not provided).(b)(6) hospital paramedics then arrived on scene and administered als (advanced life support) therapies such ivs medications and cardiac monitoring.The captain stated that the patient was properly positioned on the platform and the platform was deployed without any issues.The autopulse platform performed approximately 3 compressions, then stopped and shut off.The medics restarted the platform and it performed another 3-4 compressions, then stopped and shut off again.No user advisories were observed on the lcd display.Use of the autopulse was discontinued.The medics reverted to manual cpr (exact length of time not provided).The patient was transported to (b)(6) hospital.Patient had a history of alcoholism.An autopsy was performed.The autopsy report however, is unable to provide any insight regarding the factors that may have played a role in the patient's death.No further information was provided.

Manufacturer Narrative

It was also reported that when the device came back to the station it was noticed that 9 screws were missing on the back side.Product in complaint was returned to zoll on 04/06/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and found that the top cover, bottom cover and front cover were damaged.The reported issue of the platform missing bottom cover screws could not be confirmed.From the condition of the platform, the damages appear to have been caused by normal wear and tear.A review of the archive was performed and multiple ua 2 (compression tracking error) and ua 17 (max motor on time exceeded during active operation) codes were observed on the reported event date of (b)(6) 2015, thus confirming the reported complaint of the platform stopping compressions.It should be noted that li-ion battery (s/n (b)(4)) was being used with a low remaining capacity at the time these codes were displayed.Functional testing was also performed and no user advisories or warnings were observed.The platform performed as intended during functional evaluation.Continuous compressions were performed using a large resuscitation test fixture without any unintended stoppages.Load cell characterization was also performed which confirmed that both load cells were functioning properly.In addition, no other device deficiencies were noted during evaluation of the platform which may have caused or contributed to the ua 2 codes.Based on the evaluation the cause of the ua 2 codes was likely misalignment of the patient on the platform while compressions being performed.A definitive cause for the observed 17 codes could not be determined.An inspection of the platform's brake gap was performed, which found that the brake gap was within specification, thus ruling this out as a potential cause.Based on the archive review, the most probable cause of the ua 17 codes was use of li-ion battery (s/n (b)(4)) with a low remaining capacity.Based on the investigation, the parts identified for replacement were the top cover, bottom cover, and front cover.In summary, the reported complaint of the platform missing bottom cover screws could not be confirmed during visual inspection.The complaint of the platform stopping compressions was confirmed through archive review.The data showed that the platform stopped multiple times as a result of the ua 2 and ua 17 codes.No device deficiencies were observed during evaluation which may have caused or contributed to these ua codes.The ua 2 most likely occurred as a result of patient misalignment.The most probable cause of the ua 17 codes was use of li-ion battery (s/n (b)(4)) with a low remaining capacity.Following service, including replacement of the damaged covers, the device passed all testing criteria.Based on the information provided from the customer, the patients death is likely related to the patient's initial condition and is not related to the device or procedure.Autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.

• 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: 4737927
• MDR Text Key: 5824298
• Report Number: 3010617000-2015-00247
• 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: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2007
• 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: 40 YR
• Patient Weight: 125