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

Model Number MODEL 100

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the investigation has been completed.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, during patient use, the autopulse platform (sn (b)(4)) powered on and powered off by itself continuously.The crew reverted to manual cpr.Rosc was not achieved and the patient expired.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.

Event Description

During patient use, the autopulse platform (sn (b)(4)) kept on resetting continuously.The crew reverted to manual cpr.Rosc was not achieved and the patient expired.No further information was provided.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4) kept on resetting continuously" was confirmed during the archive data review, but not during the functional testing.No device malfunction was observed during the testing and the autopulse platform performed as intended.The load sensing system has detected a weight or load imbalance between the two load cells, due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression or take-up.The root cause for the reported complaint was due to user error.Upon visual inspection, unrelated to the reported complaint, noticed crack on the front enclosure.The probable cause for the physical damage could be due to normal wear and tear of the device or due to the damage sustained by user mishandling.The autopulse platform was manufactured in 2012 and is 7 years old, past the expected service life of 5 years.The front enclosure was replaced to address the physical damage.The autopulse platform passed the initial functional testing without any fault or error.Load cell characterization test indicated both cell modules are functioning within the specification.The archive data review showed occurrence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message around the customer reported complaint date, thus confirming the customer reported complaint.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Ua07 is an indication that the load sensing system has detected a weight/load imbalance between the two load cells.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to mitigate patient movement and press restart to clear the ua.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing without any fault or error.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9331155
• MDR Text Key: 167241061
• Report Number: 3010617000-2019-01041
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 10/31/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1