MAUDE Adverse Event Report: ZOLL CIRCULATION, INC 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 08/21/2014

Event Type  malfunction  

Event Description

It was initially reported that on (b)(6) 2014, the head restraint cable of the autopulse platform was broken.No further information was provided.The platform was subsequently returned to zoll for evaluation.During investigation, the autopulse platform displayed a system error 139 (unable to hold compression position) message.Although the customer did not report this, system error 139 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform ((b)(4)) was returned to zoll (b)(4) for analysis.Investigation results as follows: visual inspection of the returned platform shows that the head restraint wires and the short black cover were damaged and the battery latch lock was bent.The physical damages found during visual inspection confirmed the reported complaint of the head restraint cable being broken.The damages appear to have been caused by normal wear and tear (autopulse manufactured in (b)(4) 2007).A review of the autopulse archive was performed and the archive data shows that no clinical use with a patient occurred on the initial reported event date of(b)(4) 2014.However, the archive does show that a ua2 (compression tracking error) fault and system error 139 (unable to hold compression position) message occurred on (b)(6) 2014.These faults are not related to the reported complaint.Functional testing was performed and a system error was observed.It was found that the system board was at fault.Based on the investigation, the parts identified for replacement were the system processor board, blue case and all associated parts, short black cover, and the battery latch lock.In summary, the reported complaint of the head restraint cable being broken was confirmed during the visual inspection.The fault was found to be due to normal wear and tear.The ua2 fault and the system error 139 message that were observed in the archive review are unrelated to the reported complaint.The root cause for ua2 fault could not be determined.However, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The root cause for system error 139 was due to the defective system processor board.Upon replacement of all parts, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4049336
• MDR Text Key: 4812507
• Report Number: 3010617000-2014-00449
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2007
• 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