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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Cardiac Arrest (1762)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 07/27/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during both patient use and testing with a mannequin, the autopulse platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message.Customer indicated that they replaced the lifeband but the message did not clear.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform was returned to the manufacturer for evaluation on 07/27/2015.Investigation results as follows: visual inspection of the returned platform was performed and no physical damages were observed.A review of the platform's archive data was performed and no user advisory (ua) 7 messages were observed on the reported event date of (b)(6) 2015, however multiple user advisory (ua) 7 messages were observed on 07/19/2015, thus confirming the customer's reported complaint.The reported ua 7 message was also duplicated when the autopulse platform was powered on for functional testing.Further inspection determined that the single point load cell module 2 was over reporting.Based on the investigation, the part identified for replacement was the load cell module 2.In summary, the customer's reported complaint of the platform displaying a ua 7 message was confirmed through review of the platform's archive data and was also replicated when the platform was powered on for functional testing.The root cause was determined to be that load cell module 2 was not functioning.After replacement of the part identified during investigation, the platform successfully passed all final functional testing.

• 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: 5004734
• MDR Text Key: 23126648
• Report Number: 3010617000-2015-00455
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Report Date: 07/20/2015

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: 07/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• 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