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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed through evaluation and archive data review of the autopulse platform ((b)(4)).The root cause is due to a defective load cell.The archive data was reviewed and contained multiple ua 7 error message on the (b)(6) 2018 and not on the reported event date of (b)(6) 2018, thus confirming the reported event.Evaluation of the platform during initial power up, revealed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message on the user control panel.A load characterization check was performed and identified a defective load cell.Further functional testing was performed by replacing a good known load cell, this cleared the ua 7 error message; however, the platform displayed a user advisory (ua) 12 (lifeband not present) error message, this is due to an improper alignment of the belt switch cable assembly and not related to the ua 7 error message.Upon adjustment of the belt switch cable assembly, the platform passed all testing criteria and met all required specifications.Upon customer approval, replacement of the load cell will be performed.The autopulse platform is a reusable device and was manufactured on 10 jun 2015.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

As reported, the autopulse platform ((b)(4)) displayed ua 7 (discrepancy between load 1 and load 2 too large).Unspecified troubleshooting was performed; however, this did not resolve the issue.Ua 7 fault can't be cleared by the user.No known impact or patient consequence reported.

• 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 INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7524714
• MDR Text Key: 108618215
• Report Number: 3010617000-2018-00554
• 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
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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: 05/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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