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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) does not power on was not confirmed during functional testing.The autopulse platform powers on and passed the functional testing.Autopulse platform performed as intended.No physical damage was observed on the autopulse platform during visual inspection.The archive data review showed no significant discrepancies.The autopulse platform passed 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.Based on the autopulse li-ion batteries (serial #(b)(4)) and (serial #(b)(4)) archives, the batteries were mismanaged and charging practice by the customer.Battery serial #(b)(4) was defective and did not passed charging on the mcc before it was used in the autopulse platform and battery serial #(b)(4) was not fully charged when it was used in the autopulse platform.The autopulse li-ion battery (serial #(b)(4)) could not be recharged, it is defective and as a result, the archive could not be downloaded.There is no clear evidence that this battery was use on the autopulse platform.Therefore, the root cause of the platform's power issue was attributed by defective and/or use of low voltage autopulse li-ion batteries.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) does not power on.Unable to resolve the power issue, crew reverted to manual cpr and rosc was achieved.No consequences or impact to patient.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11982913
• MDR Text Key: 255633637
• Report Number: 3010617000-2021-00474
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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