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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the functional testing and on the archive data review.The root cause for the reported complaint was due to the defective load cell2, likely due to a defective component or harsh impact due to user handling.Visual inspection was performed and found no physical damage to the autopulse platform.The initial functional testing of the autopulse platform could not be performed due to user advisory (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.Review of the archive data indicated error message user advisory (ua) 07 on the customer reported event date.The load cell characterization test revealed that the load cell2 was over-reporting.The defective load cell needs to be replaced to address the error.Waiting for customer approval for repair.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 serial number (b)(4).

Event Description

During the training, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The error could not be cleared by the user.No patient involvement.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, ca
• MDR Report Key: 10324143
• MDR Text Key: 200433029
• Report Number: 3010617000-2020-00718
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• 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