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

Model Number MODEL 100

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll for investigation on 06/17/2015.Investigation results are as follows: visual inspection of the returned platform was performed and found that the battery lock clip on the autopulse was bent.In addition, the front enclosure was also observed to be cracked.From the condition of the platform, the damages appear to have been caused by normal wear and tear.A review of the platform's archive was performed and no user advisories or warnings were observed on the initial reported event date of (b)(6) 2015.When the platform was powered on during functional testing, it displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message, with nimh and li-ion batteries.Further inspection identified the cause to be that the driveshaft was out of its "home" position.The customer's reported complaint of an autopulse battery "getting stuck and being hard to release" was not confirmed.Multiple li-ion and nimh were inserted and removed from the autopulse platform and no problems were observed.The autopulse platform was run in continuous mode for 6 minutes using a test mannequin and no problems were observed.Load cell characterization testing was also performed, which found that both load cells were functioning within specification.The platform passed all functional testing.Based on the investigation, the parts identified for replacement were the front enclosure and battery lock clip.In summary, the customer's reported complaint of an autopulse battery "getting stuck and being hard to release" was not confirmed.Multiple li-ion and nimh were inserted and removed from the autopulse platform and no problems were observed, therefore a root cause could not be determined.Unrelated to the reported complaint, the platform displayed a user advisory (ua) 45 upon power up.Further inspection identified the cause to be that the driveshaft was out of its "home" position.Per the autopulse resuscitation system model 100 user guide, the autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.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 physical damages found during inspection and servicing of the device are unrelated to the reported complaint.The platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

Event Description

It was initially reported that when an autopulse li-ion battery is placed into the platform, it becomes stuck and hard to release.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.Although the customer did not report this, ua 45 is considered a reportable malfunction.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5109531
• MDR Text Key: 27061685
• Report Number: 3010617000-2015-00533
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,health
• Reporter Occupation: Other
• Report Date: 06/16/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• 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