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 Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

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 cell 2, likely due to a defective component or harsh impact due to user handling.During the visual inspection, no issues were observed.The initial functional testing of the autopulse platform could not be performed due to user advisory (ua) 07 error message displayed upon powering on.The load cell 2 needs to be replaced to address the user advisory (ua) 07 error.Review of the archive data indicated error message user advisory (ua) 07 on the customer reported event date.Additionally, the archive shows the presence of the user advisory (ua) 18 (max take-up revolution exceeded) error, unrelated to the reported complaint, and was cleared by the user.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The user advisory (ua) 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.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 patient use, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message on the screen panel.The crew was unable to clear the advisory and immediately performed manual cpr.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

• 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: 10292992
• MDR Text Key: 199659987
• Report Number: 3010617000-2020-00693
• 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: 07/17/2020

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: 07/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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