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

Model Number MODEL 100

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

Complainant alleged that during a device check by the customer, it was observed that the encoder shaft of the autopulse was too tight too rotate sometimes.Zoll (b)(4) confirmed the reported event and the platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (b)(4) was returned to the manufacturer for evaluation.Visual inspection was performed and no external damages were observed.Prior to functional evaluation, the clutch plate was inspected and the reported complaint was confirmed; the clutch plate was found to have burrs in the hex cut out and on the surface of the clutch rotor.After de-burring the clutch plate and removing the sharp edges from all 12 hex edges of the armature plate, the clutch plate was still found to be sticking and therefore required replacement to remedy the issue.Following replacement of the clutch plate, the platform was run with a test mannequin and performed as intended.The platform passed all functional testing.A review of the archive shows that no user advisories occurred on the reported event date of (b)(6) 2015.Based on the investigation, the part identified for replacement was the clutch plate.In summary, the reported complaint was confirmed during internal inspection of the device prior to performing functional testing.The clutch plate was replaced to remedy the complaint.Following service, including replacement of the clutch plate, the device 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: 4518249
• MDR Text Key: 5536168
• Report Number: 3010617000-2015-00088
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2015

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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