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

Model Number MODEL 100

Device Problems No Display/Image (1183); Use of Device Problem (1670); Noise, Audible (3273)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Event Description

During a device check, the lcd screen of the autopulse platform (sn (b)(4) was noticed blank, but the backlight was on.Also, the platform made a clicking sound upon powering on.In addition, start/continue, stop/cancel, power led (green), and alert led (red) were all simultaneously lit on the user control panel.No patient involvement.

Manufacturer Narrative

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was corrected.The reported complaint that "the lcd screen of the autopulse platform (sn 43705) was blank with the backlight being on, the platform made a clicking sound upon powering on, and all leds simultaneously lit on the user control panel" was confirmed during functional testing.During device evaluation performed at zoll, the autopulse platform failed initialization during the power-on-self-test.The autopulse platform powered on making a repetitive clicking sound while all the leds on the user control panel were lit at the same time.Also, the lcd screen was blank with no characters displayed, but the led backlight was on.The root cause of the reported complaint was the processor board (pca) failure due to failed component(s).The processor board needs to be replaced to remedy the issue.Upon visual inspection, no physical damage was observed on the returned autopulse platform.The archive data could not be downloaded as the autopulse platform failed initialization (power-on-self-test).Since the customer has received the replacement, the autopulse platform will be stored for future refurbishment sale order requests.

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15740736
• MDR Text Key: 304883055
• Report Number: 3010617000-2022-01919
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: BX
• 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: 12/05/2022

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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