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

Model Number MODEL 100

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4) displayed a red light on the control panel and blank lcd was not confirmed through review of the archive and during 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 could be due to the temporary presence of moisture in the platform caused by the user's decontamination process.During the visual inspection, a crack on the front enclosure was observed, unrelated to the reported complaint.This type of physical damage found during visual inspection is due to mishandling.The damaged front enclosure was replaced to remedy this issue.Unrelated to the reported complaint, the archive data review showed the occurrence of the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) and user advisory (ua) 20 (position out of range) error messages on the last date the platform was powered on, (b)(6) 2020.All these error messages were cleared by the customer.User advisory (ua) 45 is the clearable error message.The user advisory (ua) 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruction, to clear user advisory (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.User advisory (ua) 20 error message was due to the encoder driveshaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 error message is not resolved properly, it leads to user advisory (ua) 20 because the driveshaft is not restored at the home position.To remedy the issue, the driveshaft needs to be rotated back to the home position.The autopulse platform passed the initial functional testing without any fault or error.However, the load cell characterization test revealed that the load cell module 1 is defective, probably as a result of damage sustained by user mishandling such as a drop as indicated by the damaged front enclosure.The defective load cell was replaced to address the issue.Following service, the autopulse platform passed the run_in test using the 95% large resuscitation testing fixture (lrtf) with good known test batteries, until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.

Event Description

During the shift check, the autopulse platform (sn (b)(4) displayed a red light on the control panel and blank lcd.Per a reporter, the platform was cleaned after use with hydrogen peroxide.No patient involvement.

• 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: 10624434
• MDR Text Key: 209841549
• Report Number: 3010617000-2020-00967
• 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: 10/03/2020

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: 09/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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