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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was initially reported that the head restraints of the autopulse platform were damaged.No patient involvement was reported.No further information was provided.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 upon power up.Although the customer did not report this, ua 7 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/28/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and the initial reported complaint of damaged head restraints was confirmed.It was found that the head restraints were damaged.In addition the front and bottom covers were observed to be cracked.When the platform was powered on during functional testing, it displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large).Load cell characterization was performed and found load cell module 2 to be under reporting, causing the observed ua 7 advisory code.Following replacement of load cell module 2, the device passed functional test requirements.The platform's archive data was reviewed.There were no ua codes observed on the initial reported event date of (b)(6) 2015, whereby customer reported that the head restraints of the autopulse platform were damaged.The cause of the ua 7 code was previously identified as load cell 2 under reporting.The top cover was replaced to remedy the customer's reported complaint of the head restraints being damaged.All other damage noted during the visual inspection was remedied and load cell 2 was replaced to remedy the ua7 exhibited during initial functional testing.In summary, the initial reported complaint of the head restraint wires being damaged was confirmed through visual inspection.The root cause was determined to have been caused by user handling.Unrelated to the initial reported complaint, ua 7 was observed during power on of the platform.The ua 7 fault was attributed to load cell module 2 under-reporting.Following service, including replacement of the damaged parts, 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: 4571209
• MDR Text Key: 5459823
• Report Number: 3010617000-2015-00144
• 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: 01/13/2015

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: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2007
• 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