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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

The customer reported during a call, the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" error message when turned on.The red caution triangle on the platform illuminated.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) displayed "system error, out of service, revert to manual cpr" error message was confirmed during review of the archive data and functional testing.A review of the archive data log file indicated the occurrence of system error - 136 (invalid parameters block).The root cause of the reported complaint was the failed processor board, likely attributed to the aging of the device.The autopulse platform was manufactured in 2006 and is 18 years old, past its expected service life of 5 years.During visual inspection of the returned platform, unrelated to the reported complaint, a damaged motor cover was observed.The observed physical damage appeared to be characteristic of user mishandling.The motor cover needs to be replaced to address the observed physical damage.The archive data review indicated system error - 136 (invalid parameters block), thus confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.Replacement of the processor board is needed to remedy the system error, however, the part is not longer available.Therefore, no service was performed.The unrepaired autopulse platform was returned to the customer.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19154312
• MDR Text Key: 341286920
• Report Number: 3010617000-2024-00337
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2006
• 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