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

Model Number MODEL 100

Device Problems Device Slipped (1584); Naturally Worn (2988)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Complainant alleged that the locking tabs that hold the autopulse lifeband are worn, therefore preventing the lifeband from remaining in place.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

Autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Visual inspection of the returned platform was performed and found no anomalies.Functional testing of the platform was performed with no issues.A review of the platform archives was performed and found no anomalies.Please note, during this review, it was found that the platform was last used on 2/18/2014 and not on the reported event date of (b)(6) 2014.The die cast channel was replaced, remedying the customer's reported complaint that the "lifeband will not stay in place".The system underwent and meets all test criteria.In conclusion, the customer's reported complaint of the 'tabs that hold the lifeband being worn" cannot be confirmed, as the lifeband was not returned with the platform for investigation.However, the customer reported complaint that the "lifeband would not stay in place" was confirmed through evaluation of the returned platform.The die cast channel was replaced, after which the platform functioned as intended.

• 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: 3757025
• MDR Text Key: 17617238
• Report Number: 3003793491-2014-00194
• 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,Followup
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• 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: 04/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2011
• 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