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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the zoll platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.The death was not related to the autopulse device.The autopulse is used as an adjunct procedure 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 unexpectedly stops compressions, the interruption is similar to interruptions prescribed in the aha guidelines.Changing battery or reinserting the same battery and restart compression is quick, similar to the time necessary for rescuer rotation.Therefore, battery exchange for autopulse presents the same workflow as manual cpr in which rescuers are rotated.Hence, the patients outcome is not negatively impacted by the interruptions when compared to standard of care manual cpr.The cause of death was presumed to be patient's underlying clinical condition of cardiac arrest.

Event Description

It was reported that the autopulse platform (sn (b)(4)) displayed a "replace battery" prompt on the display screen and stopped compressions during patient use on an elderly patient (age and gender unknown) who was in cardiac arrest at an unspecified date in (b)(6) 2016.The installed autopulse lithium ion battery was removed from the platform and upon battery status check, the battery displayed four steady green leds indicating a full charge.The platform restarted after the user reinserted the battery back into the platform.It was further reported that the platform stopped compressions at least two more times and another battery was used.Inserted with another battery, the platform operated with continuous compressions until the patient was transferred to the hospital's care.According to the information, the patient subsequently expired.It was stated that the patient's death was not attributed to the device.No other information was provided.

Manufacturer Narrative

The reported event was confirmed based on the review of the archive data retrieved from the autopulse platform (sn (b)(4)); however, the reported event was not able to be reproduced during functional testing of the platform.The root cause for the user advisory (ua) 13 (battery fault detected) error message was attributed to the battery not being fully inserted into the platform; however, the root cause for the user advisory (ua) 17 (max motor on time exceeded during active operation) error messages could not be conclusively determined.Review of the archive data retrieved from the platform indicated that on 23 nov 2016, the autopulse battery (sn (b)(4)) was in use but was not fully inserted into the battery bay causing three battery lost messages which may have caused the ua 13 error message.The ua 13 error message was subsequently cleared by the user.On 18 dec 2016, the autopulse battery (sn (b)(4)) was in use and four user advisory ua 17 error messages were observed.It was noted that the platform was used on a medium sized patient and the battery had sufficient battery capacity to perform compressions.All four ua 17 error messages were cleared by the user.There were no device deficiencies found during evaluation of the platform that could have caused or contributed to the reported complaint.No error message was observed during functional testing of the platform.Inspection of the drive train motor brake gap verified that it was within the specification.The platform was subjected to three run-in tests using the returned batteries (sns (b)(4)), and the platform operated for an average of 26 minutes on each batteries with continuous compression using a light resuscitation test fixture without any issue observed.Note that the user advisory error messages are designed into the platform when one of several conditions is detected.The ua 13 and ua 17 error messages observed in the archive data can be cleared by properly inserting a fully charged battery into the platform.The autopulse user guide instructs the user that the battery should snap into place and mount flush with the platform.The finger latch for the battery should also be flush with the platform such that the red strip on the inside of the finger latch is not visible.Additionally, the returned batteries were further tested and no issues were observed.The batteries were functionally tested by inserting into the returned autopulse multi chemistry charger (sn (b)(4)) and were able to successfully charge with four steady green lights illuminated on the battery status led indicator during battery status check.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 number (b)(4).The autopulse platform is a reusable device and was manufactured on 31 jan 2008.

• 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: 6268595
• MDR Text Key: 65463955
• Report Number: 3010617000-2017-00007
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2008
• 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