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 Patient Involvement (2645)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

It was initially reported that during a demo at the customer's site, an autopulse battery was stuck in the platform.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 45 (not at "home" position after power-on/restart) message occurred on the reported event date of (b)(4) 2014.Although the customer did not report this, ua 45 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection of the returned platform showed no physical damages to the platform.However, it was observed that an autopulse li-ion battery ((b)(4)) was stuck in the platform which confirmed the initial reported complaint.Visual inspection of the battery showed that the guiding pin on the right side was damaged.This damage confirmed the reported event that the battery was stuck in the platform.A review of the battery's archive was performed.The archive data did not show any issues.A review of the autopulse platform's archive was performed and showed that multiple user advisory (ua) 45 (not at "home" position after power-on/restart) faults occurred on the reported event date of (b)(4) 2014.However, the observed ua 45 faults are not related to the initial reported complaint that the battery was stuck in the platform.Battery management assessment was performed through review of the platform's archive.The archive data shows that ua 13 (battery fault detected) faults occurred with li-ion battery ((b)(4)) and with nimh battery ((b)(4)) on the reported event date.An investigation conducted using the batteries' serial numbers found that both of the batteries were within its expected life span of 2-4 years and that they were properly maintained.Functional testing was performed and the platform passed testing.The platform ran for 6 minutes with a test mannequin and no problems were observed.Based on the investigation, no parts were identified for replacement.In summary, the initial reported complaint that the battery was stuck in the platform was confirmed during visual inspection.The fault was found to be due to the damaged guiding pin.The root cause for ua 45 faults could not be determined.Per the autopulse® resuscitation system model 100 user guide ((b)(4)), 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.The battery management assessment results are unrelated to the initial reported complaint.The root cause for ua13 could not be determined.The platform was evaluated through functional testing and 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: 4065570
• MDR Text Key: 4899585
• Report Number: 3010617000-2014-00462
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2014

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: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2007
• 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