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 Insufficient Information (4580)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint that an autopulse platform (sn (b)(6) has issues holding lifebands, and they get dislodged easily was not confirmed 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.In addition, the autopulse platform was tested with the returned customer's lifeband, and the reported issue was not replicated during testing, and the autopulse platform functioned appropriately and as intended.The visual inspection found no physical damage to the returned autopulse platform.The archive data review indicated multiple (ua) 45 and (ua) 18 (max take-up revolution exceeded) advisory messages around the customer's reported event date, unrelated to the reported complaint.User advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per autopulse hangtag - advisory codes description and action, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.The autopulse platform failed functional testing due to (ua) 45 displayed upon powering on and noted a stuck driveshaft during the internal inspection, unrelated to the reported complaint.The root cause for the (ua) 45 error was the drive shaft not being at the "home position." the (ua) 45 error message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.However, in this case, noticed a stuck driveshaft.The clutch was deburred to address the driveshaft issue and then the driveshaft was rotated to the "home position" to address the observed (ua) 45 message.Following service, the autopulse platform passed the run-in test until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.

Event Description

As reported, the autopulse platform (sn (b)(6) has issues holding lifebands, and they get dislodged easily.The issue was confirmed with multiple lifebands.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18638423
• MDR Text Key: 334508463
• Report Number: 3010617000-2024-00096
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• 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