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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

During the shift check, the lcd backlight of the autopulse platform (sn (b)(4)) was found to be not functioning, and the lcd screen was difficult to read.No patient involvement.

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Manufacturer Narrative

The customer reported a complaint that " the backlight of the autopulse platform (sn (b)(6) ) was not functioning, and the lcd screen was difficult to read" was confirmed during the visual inspection.The root cause for the reported complaint was a defective lcd, likely attributed to the device's aging.The autopulse platform was manufactured in 2007 and is 13 years old, past the expected service life of 5 years.The autopulse platform passed the initial functional testing without any fault or error.However, no light was observed from the lcd backlight, thus confirming the customer's reported complaint.The lcd screen needs to be replaced to remedy the fault.The archive data review showed no significant discrepancies or errors.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint 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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 13566631
• MDR Text Key: 286511996
• Report Number: 3010617000-2022-00165
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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