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

Model Number MODEL 100

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was initially reported that during a morning check-off, the head restraint wire of the autopulse platform was found to be cut.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.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 01/22/2015 for investigation.Investigation results as follows: the platform was visually inspected for external damages.The initial reported complaint of the head restraint wires being cut was confirmed; the wires were found to have been damaged.Unrelated to the initial reported complaint, the device's lcd was found to not be functioning properly with some of the pixels missing.In addition, a damaged ir port on the processor pca board was observed.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 over-reporting and 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 reported event date of (b)(6) 2015.There were; however, multiple ua 7 codes identified on other dates.The cause of the ua 7 codes was previously identified as load cell 2 over-reporting.Based on the investigation, the part(s) identified for replacement were the top cover, lcd, pca and load cell module.In summary, the initial reported complaint of the head restraint wires being damaged was confirmed during visual inspection.Unrelated to the initial reported complaint, ua 7 was observed during power on of the platform as well as in the platform's archive.The ua 7 fault was attributed to load cell module 2 over-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: 4564248
• MDR Text Key: 5474333
• Report Number: 3010617000-2015-00138
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• 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: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2007
• 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