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

Model Number MODEL 100

Device Problems Cut In Material (2454); Device Displays Incorrect Message (2591)

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

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Complainant alleged that the lifeband was cut and now the autopulse® platform is displaying a user advisory 45 (not at "home" position after power-on/restart) message, that is unable to be cleared.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and the following was observed: the encoder cover, front panel membrane, head restraint assembly were damaged.The battery partition cover was also found to be missing.From the condition of the platform, the damages appear to have been caused by normal wear and tear.The reported user advisory 45 (not at "home" position after power-on/restart) fault could not be duplicated during functional evaluation with multiple known, good batteries.The platform was run continuously with a test mannequin for 25 minutes with no faults observed.A review of the archive was performed and there were no reported user advisory 45 faults observed on or around the reported event date of (b)(6) 2014.Based on the investigation, the parts identified for replacement were the encoder cover, front panel membrane, head restraint assembly, and battery partition cover.In summary, the reported complaint could not be confirmed during functional evaluation.There were also no ua 45 faults observed in the archive on or around the reported event date.Following service, including replacement of the damaged and missing parts, the platform 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: 4262913
• MDR Text Key: 5032140
• Report Number: 3010617000-2014-00617
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2005
• 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