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

Model Number MODEL 100

Device Problem Inadequate Lighting (2957)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform's display light did not work and that the display was dark.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 10/15/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the battery lock pin was broken.The physical damage found during visual inspection is not related to the reported complaint that the platform's display light did not work and that the display was dark.The physical damage observed during visual inspection appears to have been caused by mishandling of the platform.A review of the autopulse platform's archive was performed and showed no sessions to have occurred on the reported event date on (b)(6) 2014.Functional testing was performed and the reported complaint was confirmed.It was observed that the display (ribbon) cable was slightly crooked on processor board at connector j15.The display cable was disconnected and the connectors were cleaned to remedy the reported display issue.A user advisory (ua) 46 (software error) fault was observed upon power up of the returned platform.However, during functional testing and multiple power up's, the ua 46 fault did not reoccur.The platform ran for 20 minutes using a large resuscitation test fixture (lrtf) and no problems were observed.Based on the initial investigation, the part identified for replacement was the battery lock pin.In summary, the reported complaint that the platform's display light did not work and that the display was dark was confirmed during functional testing.The fault was found to be due to the cable and the connectors.The physical damage found during visual inspection is unrelated to the reported complaint.The ua 46 fault observed during functional testing is also unrelated to the reported complaint.

Manufacturer Narrative

Additional investigation results for the returned platform: during final testing of the returned platform, it was observed that the display was consistently dark.It was found that the processor pca assembly was defective.Based on the investigation, the processor pca assembly was also identified for replacement.In summary, the reported complaint that the platform's display light did not work and that the display was dark was confirmed during functional testing.The fault was found to be due to the processor pca assembly.Upon replacement of all parts, the platform was re-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; 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: 4217969
• MDR Text Key: 4976661
• Report Number: 3010617000-2014-00582
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2013
• 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