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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2020

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 ua7 was due to defective load cells.The cracked front enclosure and defective load cell were likely attributed to mishandling such as a drop.Upon visual inspection, cracked front enclosure was observed likely due to user mishandling such as a drop.The initial functional testing of the autopulse platform could not be performed due to ua 07 error message displayed upon powering on.The archive data review showed occurrence of multiple ua07 error message.The load sensing system has detected a weight/load imbalance between the two load cells.Both load cells needs to be replaced to address the ua07 error.In addition, unrelated to the reported complaint, noticed that the date and time in the archive data are corrupted.The processor board needs to be replaced to address the date and time issue.The probable root cause for the observed date and time issue is due to normal wear and tear.The autopulse platform was manufactured in 2007 and is 12 years old, well beyond the expected service life of 5 years.Waiting for customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number (b)(4).Ccr (b)(4) reported on 02 nov 2011, both load cells were replaced.

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message on the user control panel.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10304876
• MDR Text Key: 199893549
• Report Number: 3010617000-2020-00697
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2007
• 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