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

Model Number MODEL 100

Device Problems Break (1069); Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, the head restraint of autopulse platform was found to be damaged and the load plate screws were missing.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message.Although the customer did not report this, ua 7 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.The reported complaint was confirmed; visual inspection was performed and the head restraint wire and bottom enclosure were found to be damaged as well the load plate screw missing.From the condition of the returned unit, the damages appear to have been due to wear and tear.Unrelated to the reported complaint, a user advisory 7 (discrepancy between load 1 and load 2 too large) was displayed during functional testing.Further inspection identified the cause of the ua 7 to be a single point load cell not functioning properly.It was also observed that the platform was not generating the expected audible tone while performing compressions.Testing identified that this was attributed to the processor board not functioning properly.A review of the archive shows no user advisories occurring on the reported event date of (b)(6) 2014.Based on the investigation, the part(s) identified for replacement are the top cover, bottom enclosure, single point load cell, and processor board.In summary, the reported complaint was confirmed during visual inspection and attributed to wear and tear.Unrelated to the reported complaint, a user advisory 7 (discrepancy between load 1 and load 2 too large) was displayed during functional testing and found to have been caused by a load cell not functioning.The processor board was also found to not be functioning properly, leading to no audible tone when the platform was performing compressions.Following service, 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: 4170399
• MDR Text Key: 5160764
• Report Number: 3010617000-2014-00527
• 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: 08/21/2014

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: 08/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2007
• 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