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

Model Number MODEL 100

Device Problem Break (1069)

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

Event Date 04/24/2015

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, it was observed that the battery connector inside the battery bay of the autopulse platform was damaged.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 to the manufacturer for evaluation.Visual inspection was performed and the battery connector inside of the battery bay was damaged, thus confirming the reported complaint.Unrelated to the reported issue, the bottom enclosure, load plate cover, and battery latch lock were also found to have been damaged.From the condition of the platform, the damages appear to have been caused by normal wear and tear.Functional testing was performed and the platform displayed a user advisory 7 (discrepancy between load 1 and load 2 too large) fault.Further inspection determined that the load cell modules were not functioning properly.Following replacement of the load cell modules, 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 observed 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 battery connector, bottom enclosure, load plate cover, battery latch lock and load cell modules.In summary, the reported complaint of the physical damage to the battery connector was confirmed based on visual inspection and attributed to wear and tear.Unrelated to the reported complaint, the platform displayed a ua 7 during functional testing due to the load cell modules not functioning properly.Following replacement of the load cell modules, the platform passed functional testing.Following service, including replacement of the battery connector and load cell modules, 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: 4773091
• MDR Text Key: 18068844
• Report Number: 3010617000-2015-00288
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2015

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: 8700-0730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2011
• 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