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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

During servicing at zoll, the autopulse platform (b)(6) failed initial functional testing due to fault 27 (encoder fault).The root cause for the observed fault was due to a failure of the integrated encoder gearbox, likely attributed to the age of the device.The autopulse platform was manufactured in 2008 and is 16 years old, past its expected service life of 5 years.Upon visual inspection, a cracked /damaged top cover and a hole that affects the watertight seal of the load plate cover were observed.The probable root cause for the observed physical damages was due to mishandling.Also, the brake gap was too wide (out of specification), likely attributed to wear and tear due to the age of the device.The initial functional testing of the ap platform could not be performed due to the displayed fault 27 (encoder fault).The encoder will need to be replaced to remedy the fault code.However, the repair was rejected by the customer and the device will be disposed of by zoll germany.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints for autopulse platform with (b)(6).

Event Description

During servicing at zoll, the autopulse platform (b)(6) failed initial functional testing due to fault 27 (encoder fault).No patient involvement.

• 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: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18813467
• MDR Text Key: 336790076
• Report Number: 3010617000-2024-00176
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• 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