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

Model Number MODEL 100

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a training session, the middle portion of the autopulse® platform display was dark and then unreadable signs were seen.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows no physical damage to the platform.A review of the autopulse archive was performed and the archive data shows that user advisories (uas) 45 (not at "home" position after power-on/restart) and 12 (lifeband® not present) occurred on the reported event date of (b)(6) 2014.However, these user advisories are not related to the reported complaint.Functional testing was performed and the reported issue could not be reproduced.The autopulse platform ran for 5 minutes with the test mannequin and additional minutes with the large resuscitation test fixture (lrtf) and no problems were observed.The platform passed functional testing.Based on the investigation, the lcd display will be replaced as a precaution.In summary, the reported complaint was not confirmed during visual inspection or during functional testing.The user advisories noted in the archive review are unrelated to the reported complaint.The root cause for ua45 and ua12 could not be determined.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.User advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.Upon replacement of the lcd display, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4004199
• MDR Text Key: 4773352
• Report Number: 3010617000-2014-00410
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2009
• 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