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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (b)(6) switched off after approximately 50 seconds was confirmed during the archive data review but was not confirmed during functional testing.According to the archive, the platform switched off in sleep mode during testing without a manikin, and during testing with a manikin after a displayed user advisory was not cleared, which is normal and not an error.No malfunction was found during testing at zoll, and the autopulse platform functioned appropriately and as intended.During visual inspection, unrelated to the reported complaint, the load plate cover had a hole, which affects the watertight seal, and the front enclosure was cracked/damaged.The observed physical damage appeared to be the characteristics of user mishandling.The load plate cover and front enclosure were replaced to address the issue.Also unrelated to the reported complaint, the brake gap was out-of-specification (too wide), which is likely attributed to the age of the device/normal wear and tear.The autopulse platform was manufactured in 2013 and is 11 years old, well past its expected serviceable life of 5 years.The brake gap was adjusted to remedy the issue.The customer reported a switch-off of the device in sleep mode and a switch-off during use with manikin, which was confirmed based on the archive review.However, switching off in sleep mode is normal, this is not an error.The device will power off to save the battery power.According to the log file, the switch-off observed during testing with a manikin occurred after user advisory (ua) 02 (compression tracking error) was displayed, likely due to an incorrectly positioned manikin or an open lifeband.The autopulse platform passed the initial functional test without any fault or error.The customer reported complaint and (ua) 02 observed in the archive were not reproduced during the functional testing using the small and large manikin.User advisory is normally a clearable advisory message and 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 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.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.

Event Description

The customer reported the autopulse platform (b)(6) switched off after approximately 50 seconds.This was observed during testing with a dummy and when there was no mannequin on the platform.No error messages were observed.The platform was tested with multiple batteries but the platform still switched off.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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18988107
• MDR Text Key: 338728495
• Report Number: 3010617000-2024-00247
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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