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

Model Number MODEL 100

Device Problems Retraction Problem (1536); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

It was reported that during testing at the fire station, the autopulse lifeband would not retract and no compressions were performed by the platform.No error codes were observed on the lcd display.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n 21817) was returned for evaluation.Visual inspection was performed and the following was identified: the head restraints wire were broken, the front enclosure, bottom enclosure, and battery lock were damaged.The lcd was also distorted with a vertical line running across the display.From the condition of the platform, the damages appear to have been caused by normal wear and tear.Functional testing was performed and the reported issue of the platform not retracting the lifeband and subsequently not performing compressions was confirmed.The platform displayed a user advisory 7 (discrepancy between load 1 and load 2 too large) during power up.Further inspection identified the cause to be that both load cell modules were not functioning properly.After replacing the load cell modules, the platform passed functional testing and no user advisories or other issues were observed.A review of the archive was performed and no user advisories were observed on the reported event date of (b)(6) 2015.However, consistent with the observations made during functional testing, the archive does show that multiple ua 7 codes occurred on (b)(6) 2015.Based on the investigation, the parts identified for replacement were the top cover (including head restraint wires), the front enclosure, bottom enclosure, battery lock, lcd display, and both load cell modules.In summary, the reported complaint was confirmed during functional testing as well as archive review and is attributed to both load cell modules being defective.Following service, including replacement of the load cells, 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: 4760642
• MDR Text Key: 5780698
• Report Number: 3010617000-2015-00262
• 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: 04/15/2015

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2008
• 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