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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) stopped compression and displayed an unknown user advisory (ua) on the user control panel was not confirmed during functional testing; however was confirmed, during archive data review.Based on the archive review, the unknown error message observed by the customer was user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).The probable root cause was due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression or take-up.During visual inspection, the platform was observed with the drive shaft exhibiting binding and resistance due to a stick clutch.This observation is not related to the reported event.The archive data indicated user advisory (ua) 7 (discrepancy between load 1 and load 2 too large).The load sensing system has detected a weight/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.During functional testing the platform was tested using a good known autopulse li-ion battery with a large resuscitation test fixture and performed with compression without error.There was no device malfunction observed.A load characterization check was performed and confirmed that both load cell modules are functioning within the specification.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The error messages observed in the archive are easily clearable by user.Ua 7 error message alerts the operator that the patient is out of position and not properly centered in the platform.This user advisory will persist until the patient is properly aligned.Per the autopulse user guide instruction, error message can be cleared by ensuring that the patient and the lifeband are align and then restarting the platform.After deburring the clutch plate, the autopulse 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.

Event Description

During patient use, the autopulse platform (sn (b)(4)) stopped compression and displayed an unknown error message.The user replaced the lifeband twice with a fully charged li-ion battery but was unable to clear the unknown error message.The crew immediately preformed manual cpr.No consequences or impact to patient.Based on the archive review, the unknown error message observed by the customer was user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10280898
• MDR Text Key: 199103949
• Report Number: 3010617000-2020-00684
• 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: 07/15/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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