MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY; LI-ION BATTERY, RECHARGEABLE

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery for investigation.A supplemental report will be filed when the product is returned and 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, when the autopulse platform (sn (b)(4)) was used on a patient weighed around (b)(6) lbs., it stopped compressions and displayed error message after performing 30 seconds of compressions.The user attempted to fix the errors, but the issue persisted.The user 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)) stopped compressions and displayed user advisory (ua) 17 (max motor on time exceeded during active operation) error message after performing 30 seconds of compressions.The patient weighed around 180 lbs.The user power-cycled the platform multiple times, however, the error message could not be cleared.The user reverted to manual cpr.Rosc was not achieved and the patient expired.Per user, the autopulse li-ion battery used during the call was a new battery.Please see the following related mfr report: mfr 3010617000-2019-00849 for the autopulse platform.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY, RECHARGEABLE
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 9136974
• MDR Text Key: 166369837
• Report Number: 3010617000-2019-00935
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D163369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0
• Patient Weight: 82