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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6)) displaying user advisory (ua) 45 (not at "home" position after power-on/restart) was confirmed in the archive data and during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position.The ua45 advisory 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, it was noticed that the encoder driveshaft was difficult to rotate and exhibited binding and resistance, most likely due to wear and tear of the device.The autopulse platform was manufactured in january 2010 and is over 14 years old, well beyond its expected service life of 5 years.The reported complaint of the autopulse platform displaying user advisory (ua) 12 (lifeband not present) was confirmed in the archive data, but it was not replicated during functional testing.Visual inspection revealed that the screw bosses on the top cover were cracked, and the lcd screen backlight was flickering, unrelated to the reported complaint.These observations could be related to the age of the platform.The top cover set screw boss requires reinforcement with glue and putty, and the lcd screen will need to be replaced to address the observed issues.During further inspection, it was noticed that the power distribution board (pdb) revision level was below 6 and needed to be updated, attributed to the age of the platform.The archive data review indicated multiple ua45 and ua12 advisory messages on the reported event date, confirming the customer's reported complaint.The ua12 advisory message was cleared and did not reproduce during functional testing at zoll.User advisory is normally a clearable error message, and it is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory (ua) 12 is an indication that autopulse has detected that the lifeband is not properly installed.The recommended action to take for this type of user advisory is: ensure that the band clip (underneath the device) is properly seated in the driveshaft and can freely rotate after insertion.The preliminary functional test failed as the autopulse platform displayed a ua45 advisory message upon powering up, confirming the reported complaint.During the investigation, it was noted that the platform's driveshaft was not rotating smoothly, exhibiting binding and resistance due to having a sticky clutch plate.This is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, attributed to wear and tear.The sticky clutch plate did not allow the driveshaft to rotate freely, causing the ua45 advisory message to persist.The clutch plate will be either deburred or replaced to address the issue.The belt switch assembly was evaluated as a possible root cause for the reported ua12; however, it was observed within the specification.The reported ua12 advisory message could not be replicated.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

Event Description

The customer reported that upon powering on, the autopulse platform (sn (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart).The customer tried to clear the advisory message by pulling up the lifeband, but the ua45 persisted.The customer attempted to return the driveshaft to "home" position using the administrative menu, following instructions from zoll tech support.In the process, the customer cut the lifeband (leaving only the band clip), to make it easier to rotate the driveshaft to "home" position.However, the ua45 did not clear.There is no complaint or issue reported on the lifeband.The customer powered off/on the platform to further troubleshoot the issue.Upon powering up, the platform displayed a user advisory (ua) 12 (lifeband not present).No patient involvement.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18862608
• MDR Text Key: 337447716
• Report Number: 3010617000-2024-00204
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/07/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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