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

Model Number MODEL 100

Device Problems Component Falling (1105); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a device check performed by the distributor, the autopulse lifeband fell out of the autopulse platform.The distributor reported that the distance between the black tabs on the platform that hold the lifeband in place is too wide.They tried different lifebands but the issue would not resolve.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(4) /2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection was performed and the customer's complaint was confirmed during visual inspection.The platform was functionally tested and passed all test requirements.There were no user advisories noted on the reported event date of (b)(6) 2014.Based on the investigation, the part identified for replacement was the channel die cast assembly.In summary, the reported complaint was confirmed during visual inspection and attributed to the platform channel die cast assembly being wider than intended.

• 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: 4292081
• MDR Text Key: 18031544
• Report Number: 3010617000-2014-00637
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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