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

Model Number MODEL 100

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591)

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

Event Date 10/08/2014

Event Type  malfunction  

Event Description

It was initially reported that the rubber coating over the power switch of the autopulse platform was missing.Customer indicated that the platform worked fine.No adverse patient sequelae was reported.No other issues were reported and no further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 45 (not at "home" position after power-on/restart) message occurred on the reported event date of (b)(6) 2014.Although the customer did not report this, ua 45 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 10/15/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found the rubber coating over the power switch to be missing, the load plate cover to be torn and damaged and the bumper to be damaged.The returned platform underwent and passed initial functional testing.The system was turned on/off with no problems and ran for 20 minutes using a large resuscitation test fixture (lrtf) with no anomalies or errors exhibited.A review of the platform's archive was performed and found no anomalies on the reported event date of (b)(6) 2014 related to the customer's initial reported complaint.The archive does show that the platform exhibited a user advisory (ua) 45 (not at "home" position after power-on/restart) when it was powered on.The archive also shows that there was no load on the platform when the ua 45 occurred.Therefore, it was determined to have happened during shift check and not while in use on a patient.Per the autopulse technical service guide (p/n 11377-006), ua 45 is exhibited when the lifeband is not fully extended or if the encoder is not in the "home" position.As there were no issues identified during functional testing associated with ua 45, the probable root cause of the exhibited ua 45 was determined to be that the lifeband was not fully extended, causing the encoder to not be at the "home" position.The autopulse® was designed to exhibit ua 45 to prevent patient harm.The power button was replaced to remedy the customer's initial reported complaint.Additional parts replaced that were unrelated to the initial reported complaint include: the compression spring, bumper, and the load plate cover, the clutch plate was also cleaned.The platform underwent and passed all final functional testing.In summary, the customer's initial reported complaint of the rubber coating on the power switch being missing was confirmed through visual inspection of the returned platform.The root cause was determined to be normal wear and tear.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4244529
• MDR Text Key: 20016862
• Report Number: 3010617000-2014-00605
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• 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: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2006
• 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