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

Model Number MODEL 100

Device Problem Retraction Problem (1536)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse lifeband would not retract at all.Customer can hear the driveshaft run but the lifeband will not retract.A different lifeband was used but gave the same results.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: the autopulse platform was returned for evaluation.Visual inspection was performed and the following was confirmed: the front enclosure and battery lock were damaged.From the condition of the returned platform, the damages appear to be due to normal wear and tear.During power on of the platform prior to testing, a user advisory (ua) 45 (not at "home" position after power-on/restart) message was displayed.Inspection of the device confirmed this was caused by the driveshaft being out of its home position.Following re-positioning of the driveshaft, the fault was cleared and functional testing was continued.During testing, the reported issue of the lifeband not retracting could not be replicated.The platform was run with a test manikin for 17 minutes and an additional 7 minutes with a large resuscitation test fixture (lrtf) with no faults found.A review of the archive did not show any user advisories occurring on the reported event date of (b)(6) 2014.The archive does however show that on (b)(6) 2013, multiple ua 45 faults had occurred, consistent with the customer reported issue.Based on the investigation, the part(s) identified for replacement are the front enclosure and battery lock.In summary, the reported complaint was confirmed.Ua 45 faults were observed in the archive as well as during power on of the platform prior to functional testing.Inspection of the platform identified the cause to be the driveshaft being out of its home position.Following service, including replacement of the damaged parts and repositioning of the driveshaft, 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: 3765560
• MDR Text Key: 18362174
• Report Number: 3003793491-2014-00205
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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