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

Model Number MODEL 100

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a "system error, out of service, revert to manual cpr" message.Caller stated that the fan came on, but the lifeband did not retract when the green "start" button was pressed.The platform did not respond and displayed the "system error, out of service, revert to manual cpr" message after two minutes, then powered off.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/02/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the battery lock was bent.The physical damage found during visual inspection is not related to the reported complaint.The damage appears to have been caused by normal wear and tear (autopulse manufactured in september of 2009).A review of the archive was performed and the reported complaint of a "system error, out of service, revert to manual cpr" message displayed on the platform after two minutes and the platform shutting down was confirmed.The archive data shows that two sessions of two minute time out's occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue of a "system error, out of service, revert to manual cpr" message was verified.Upon power up of the platform, the "system error, out of service, revert to manual cpr" (error code 203) message was observed.The error was cleared and the platform ran for 15 minutes with no problems observed.Based on the investigation, the part identified for replacement is the battery lock.In summary, the reported complaint of a "system error, out of service, revert to manual cpr" message displayed on the platform after two minutes and the platform shutting down was confirmed based on the archive review.The system error message was also verified during functional testing.The error message was cleared and the platform passed functional test.The physical damage found during visual inspection is unrelated to the reported complaint.Upon replacement of the battery lock and clearing the error message, the platform 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: 3885110
• MDR Text Key: 20297036
• Report Number: 3003793491-2014-00286
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/27/2014

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: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2009
• 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