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

Model Number MODEL 100

Device Problems Image Display Error/Artifact (1304); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, there were horizontal lines on the autopulse platform's screen.In addition, a clicking noise was heard upon power up of the platform.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 12/04/2014 for investigation.Investigation results as follows: visual inspection was performed and the battery lock pin was found to be damaged.From the condition of the returned unit, the damage appears to have been due to wear and tear.Upon powering on the device, the distorted display was observed, thus confirming the reported complaint.Further inspection identified that there was water ingress on and around the processor board causing the board to not function properly leading to the distorted display.After cleaning the processor board, functional testing with a test mannequin was performed for approximately 15 minutes with no faults found.Due to the water ingress at the processor board, the platform's archive could not be retrieved for analysis.Based on the investigation, the parts identified for replacement were the battery lock pin and processor board.In summary, the reported complaint was confirmed during functional inspection and attributed to water ingress on and around the processor board leading to the distorted platform display.Following service, including replacement of the processor board and battery lock pin, the device passed all testing criteria.

• 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: 4334985
• MDR Text Key: 5249214
• Report Number: 3010617000-2014-00664
• 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: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• 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: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2010
• 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