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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) stopped compressions" was confirmed during the archive data review but not during the functional testing.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.The probable root cause for the reported complaint was due to the incomplete reconditioning of the li-ion battery (sn (b)(4)) due to battery mismanagement and charging practice by the user.Zoll representative experienced an issue with downloading the archive data using the irda (infrared data association) cable, unrelated to the reported complaint.The issue was due to the partially corrupted archive log likely caused by overfilled storage buffer on the processor board.The platform software was reset to resolve the observed issue.Upon visual inspection, no physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.There was no device malfunction observed.A review of the retrieved archive data shows the li-ion battery sn (b)(4) with 1416 mah remaining capacity equivalent to four green lights was inserted into the platform.The platform was powered on twice and displayed user advisory (ua) 04 (battery charge state too low) error message.This indicates that the battery was removed from the multi-chemistry charger before finishing the battery charging cycle or during the battery conditioning cycle.The autopulse power system user guide states: do not remove a battery from the battery charger until its charging completes, or the battery's run time will be reduced.Do not remove a battery from the battery charger during a test-cycle, or the battery's run time may be reduced.If a battery is removed during a test-cycle, the battery charger will automatically restart the test-cycle the next time the battery is inserted into it.The platform was tested with the large resuscitation test fixture (lrtf) equivalent to (b)(4) lbs with good known test batteries until discharged without any fault or error.Following service, the autopulse platform passed the final testing without any fault or error.

Event Description

During patient use, the autopulse platform (sn (b)(4)) stopped compressions.The crews reverted to manual cpr.No consequences or impact to the patient.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192955
• MDR Report Key: 10440550
• MDR Text Key: 204053924
• Report Number: 3010617000-2020-00808
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2020
• 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: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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