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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Type  malfunction  

Event Description

The customer reported during shift check, the autopulse platform (b)(6) would not start compressions and displayed user advisory (ua) 12 (lifeband not present) message.No patient involvement.

Manufacturer Narrative

The reported complaint of the autopulse platform (b)(6) would not start compressions and displayed user advisory (ua) 12 (lifeband not present) message was confirmed during archive review and functional testing.A contact on the reset switch has come off (rotted off).The root cause of the error was a failed reset switch cable, likely attributed to the age of the device.The autopulse platform was manufactured in april 2014 and is nearly 10 years old, past its expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, a damaged/cracked front enclosure was observed.The observed physical damage appeared to be characteristic of user mishandling.The front enclosure was replaced to address the observed physical damage.Based on archive data review, user advisory (ua) 12 (lifeband not present) errors were observed, thus, confirming the reported complaint.The autopulse platform failed the initial functional testing due to the (ua) 12 displayed upon powering on, confirming the reported complaint.The reset switch cable was replaced to remedy the (ua) 12 error.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with (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: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18632628
• MDR Text Key: 334446767
• Report Number: 3010617000-2024-00115
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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