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 12/02/2014 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 reported complaint was confirmed during visual inspection.The platform was run for 15 minutes using an lrtf (large resuscitation test fixture) equivalent to a 250 pound patient with no problems encountered.Archive data showed that multiple user advisory 18 (max take-up revolutions exceeded) codes occurred on the reported event date of (b)(6) 2014.There were no mechanical issues observed with the platform during evaluation that could may have caused or contributed to the observed ua 18 codes.Based on the archive data, the code occurred as expected, due to no load being placed on the platform while it was in operation.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 was attributed to the platform channel die cast assembly being wider than intended.Unrelated to the reported event, the archive showed that multiple ua 18 codes occurred on the reported event date.The cause was identified as no load placed on platform while it was in operation.

• 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: 4292196
• MDR Text Key: 5080592
• Report Number: 3010617000-2014-00639
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2011
• 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