MAUDE Adverse Event Report: ZOLL CIRCULATION, INC 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 01/27/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, it was found that multiple lifebands would not remain in place when the lifeband cover plate was inserted into the designated locking tabs of the autopulse.The same lifebands clip into other autopulse platforms fine.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll circulation on (b)(6) 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 for evaluation.Visual inspection was performed and the following was observed: the battery lock was damaged.The reported complaint of the lifeband not securely fitting into the channel was observed during functional evaluation.No other issues were observed.A review of the archive was performed and no sessions were found to have been performed on the reported event date of (b)(6) 2014.Parts replaced: based on the investigation, the part(s) identified for replacement are the battery lock and die cast channel assembly.In summary, the reported complaint was confirmed during functional evaluation.Following service, including replacement of the die cast channel and battery lock, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3640642
• MDR Text Key: 20636417
• Report Number: 3003793491-2014-00104
• 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: Paramedic
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• 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: 02/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2011
• 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