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

Model Number MODEL 100

Device Problem Sticking (1597)

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

Event Date 01/03/2014

Event Type  malfunction  

Event Description

It was initially reported that the driveshaft of the autopulse was frozen and could not be budged.Customer was unable to remove the lifeband after the platform was used on a call.The platform worked fine during the code.However, the crew could not get the driveshaft to rotate back to "home" position to remove the lifeband.No error messages were reported.This event was not considered reportable because the autopulse worked as intended during the code and no adverse patient sequelae was reported.The autopulse was returned to zoll for investigation.During investigation of the returned platform, it was found that a user advisory 45 (not at "home" position after power-on/restart) message had occurred on the reported event date of (b)(6) 2014.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection results: visual inspection was performed and the reported complaint was confirmed; the driveshaft was found to have seized and was out of its home position.The cause was found to be a damaged clutch plate which was preventing the shaft from spinning freely.Other physical damages unrelated to the reported complaint included a damaged front enclosure and battery lock.From the condition of the platform, the physical damages appeared to have been due to normal wear and tear.Functional inspection results: functional testing was performed and a user advisory (ua) 45 fault (not at "home" position after power-on/restart) was observed when the platform was powered on.This was considered an expected fault since the autopulse is designed to exhibit a ua 45 when the driveshaft is out of its home position.Archive review results: a review of the archive was performed and found that a ua 45 fault had occurred on the reported event date of (b)(6) 2014, consistent with the driveshaft seizing.Battery management assessment: the reported issue is considered to be unrelated to battery management.Parts replaced: based on the initial investigation, the part identified for replacement in order to remedy the complaint was the clutch plate.The battery lock and front enclosure were also replaced, but were unrelated to the reported complaint.Conclusion: in summary, the reported complaint was confirmed based on visual inspection.The driveshaft was confirmed to have seized out of its home position due to a damaged clutch plate.Ua 45 faults, consistent with the driveshaft being out of its home position, were also observed during power on of the platform as well as through archive review.The damaged enclosure and battery lock are considered unrelated to the reported complaint.Following service, including replacement of the damaged components, the device 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: 3658894
• MDR Text Key: 4281322
• Report Number: 3003793491-2014-00127
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2008
• 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