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

Model Number MODEL 100

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, the autopulse platform appeared to be damaged on the back of the unit where the lifeband connects.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the platform exhibited a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) fault.Although the customer did not report this, a ua 7 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and the lifeband belt clip retainer was damaged, thus confirming the reported complaint.Unrelated to the reported issue, the lcd was also found to have been damaged.From the condition of the platform, the damages appear to have been caused by normal wear and tear.Initial functional testing was unable to be performed as the platform displayed a user advisory 7 (discrepancy between load 1 and load 2 too large) fault upon power up.Further inspection determined that the cause was load cell 2 module not functioning properly.Following replacement of the load cell module, the device passed all functional testing.A review of the archive was performed and there were no user advisory codes observed on the reported event date.However, consistent with the ua 7 observed during functional testing, multiple ua 7 codes were seen on other dates.Based on the investigation, the parts identified for replacement were the belt clip retainer, lcd, and load cell module 2.In summary, the reported complaint of the physical damage to the belt clip retainer was confirmed based on visual inspection and is attributed to wear and tear.Unrelated to the reported complaint, the platform displayed a ua 7 during functional testing due to load cell module 2 not functioning properly.Following replacement of the load cell module, the platform passed functional testing.Following service, including replacement of the belt clip retainer and load cell module, the device passed all testing criteria.

• 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: 4773327
• MDR Text Key: 5794883
• Report Number: 3010617000-2015-00289
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2015

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: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2007
• 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