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

Model Number MODEL 100

Device Problem No Display/Image (1183)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The customer reported that the lcd backlight flickers on the autopulse platform (sn (b)(6)) and the screen is blank.According to the reporter, aside from the screen problem, the platform is completely operational.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that the backlight of the lcd on the autopulse platform (sn (b)(6)) flicker was confirmed during the visual inspection; however, the display was still visible under the light.The root cause for the reported complaint was a failed lcd, likely attributed to wear and tear and/or mishandling.The autopulse platform was manufactured in october 2010 and is more than 13 years old, past the expected serviceable life of five years.The lcd was replaced to address the observed issue.Visual inspection of the returned autopulse platform revealed a cracked front enclosure, unrelated to the reported complaint.The observed physical damage could be attributed to user mishandling.The front enclosure was replaced to address the issue.In addition, unrelated to the reported complaint, 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.Upon review of the archive data, no significant discrepancies were found.The autopulse platform passed the initial functional testing without any fault or error.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number (b)(6).

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18813434
• MDR Text Key: 336744267
• Report Number: 3010617000-2024-00178
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/29/2024

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2010
• 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