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

Model Number MODEL 100

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that during a morning shift check, the autopulse platform displayed a "system error, out of service, revert to manual cpr" message that could not be cleared.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 11/11/2014 for investigation.Investigation results as follows: visual inspection was performed and the battery lock was observed to have been bent.The platform was functionally tested and the reported complaint was confirmed; the platform displayed a "system error" message (latch error code 71) during power up.After clearing the error, the platform was tested using a mannequin and ran for approximately 30 minutes with no faults observed.A review of the platform's archive did not show any user advisory codes or error messages occurring on the reported event date of (b)(6) 2014.Based on the investigation, the part identified for replacement was the damaged battery lock.In summary, the reported complaint of the platform displaying a "system error" message was confirmed upon functional testing.A latch error code 71 was observed when the platform was powered on.The error message was cleared.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 4281682
• MDR Text Key: 5293640
• Report Number: 3010617000-2014-00626
• 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: 11/04/2014

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: 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: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2008
• 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