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

Model Number MODEL 100

Device Problems Loose or Intermittent Connection (1371); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the autopulse platform (sn (b)(4)) found no functional issue.The platform was functionally tested with a known good autopulse lithium-ion battery and operated using a large resuscitation test fixture performing continuous compressions without error until the battery was discharged.Review of the archive data revealed three "battery lost" events involving three autopulse batteries occurring one after the other observed on (b)(6) 2017, confirming the report of the platform powering off during use.On all of these three events, the platform displayed a user advisory (ua) 3 (error communicating with battery controller) error message, the platform lost connection with the battery, and powered off.On the third inserted battery, a user advisory (ua) 3 (battery charge state too low) error message and replace battery event was observed indicating that the battery state of charge was low.Likely, the batteries were not securely/properly inserted into the battery compartment in the platform.Per the autopulse user guide, the battery should snap into place and mount flush with the autopulse platform.As part of routine service during testing, the platform was examined and found physical damages.This observation is unrelated to the reported event.Upon customer approval, the damaged parts will be replaced and the device will be further tested to full specification.The autopulse platform is a reusable device and was manufactured on 19 jul 2005.It has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, autopulse performed compression, a battery change was performed after the first stoppage.The battery was removed and reinserted when a second stoppage occurred with the platform.The device then continuously provided compression.A return of spontaneous circulation (rosc) was not achieved upon reaching hospital.For a trained user, the time to change the battery should be quick, and similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.The short interruption of removing and inserting a battery will not negatively impact the patient outcome.The cause of patient's death was likely to be caused by the patient's underlying condition.

Event Description

As reported, the autopulse platform (sn (b)(4)) was used on a patient and powered off after performing compressions for an unspecified amount of time.The user exchanged the battery; however, the same issue was observed.Following this the user removed the battery and reinserted it into the platform and this resolved the issue.The length of delay was not specified.The platform was able to function as intended throughout the emergency call; however, the patient did not achieve a return of spontaneous circulation and was pronounced dead upon reaching the hospital.The customer stated that the patient's outcome was not attributed to the device.Additional information from the reporter stated that the emergency team arrived and found the patient to be responsive to verbal stimulus and no bystander cpr was performed.No issue was found on the platform during deployment state.The li-ion batteries used at the time of the event were fully charged and they were securely/properly inserted in the platform.No further information was provided.

• 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: 6720298
• MDR Text Key: 80261233
• Report Number: 3010617000-2017-00480
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• 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: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2005
• 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
• Patient Weight: 100