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

Model Number MODEL 100

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

Complainant reported that during a device check, it was observed that the autopulse® platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.Complainant also alleged that the drive shaft was too tight to rotate.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was initially received by zoll (b)(4).Zoll (b)(4) was able to confirm the customer's reported complaint that the "driveshaft was too tight to rotate".Product in complaint was returned to zoll (b)(4) for further investigation.A supplemental report will be filed once the investigation has been completed.

Manufacturer Narrative

(b)(4).The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform revealed that there was no lcd backlight.The physical damage found during visual inspection is not related to the reported event of the driveshaft being too tight to rotate and user advisory (ua) 45 (not at "home" position after power-on/restart) being displayed.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 12/2011).A review of the archive was performed and the reported complaint that the platform displayed a ua45 was confirmed.The archive data shows that multiple user advisory 45 messages occurred on the reported event date of (b)(6) 2014.The lifeband straps were not pulled completely out prior to turning the device on.Furthermore, fault ua12 (lifeband not present) was also observed on the reported event date.However, this user advisory is not related to the reported complaint.Prior to returning the platform back to zoll (b)(4) for service, the customer rotated the driveshaft back to the "home" position, therefore the error was cleared.Functional testing was performed and the reported issue of the ua45 could not be reproduced.The root cause for the ua45 could not be determined.However, per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.During testing, the encoder was detected to be slightly sticky, therefore confirming the reported issue of the driveshaft being too tight to rotate.The fault was found to be due to the clutch plate being worn.Based on the initial investigation, the parts identified for replacement were the lcd and the clutch plate.In summary, the reported complaint of the drive shaft being too tight to rotate was confirmed during functional testing.The fault was found to be due the worn-out clutch plate.The fault ua45 (not at "home" position after power-on/restart) was confirmed based on the archive review but could not be reproduced during functional testing.The physical damage found during visual inspection is unrelated to the reported complaint.The observed ua12 in the archive data is also unrelated to the reported complaint.The root cause for ua12 could not be determined.However, per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.Upon replacement of the lcd and the clutch plate, 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: 3854818
• MDR Text Key: 4617895
• Report Number: 3003793491-2014-00272
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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