MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number	8700-0701
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse lifeband in complaint was returned to zoll on 14 march 2017, for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
During a shift check, it was observed that the lifeband alignment tab on the new lifeband (lot# 63423) was detached.There was no patient involvement reported.
Additional Manufacturer Narrative
The primary complaint was confirmed during visual inspection of the returned lifeband.The root cause of the issue is due to a broken/loose male locator of the lifeband.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6432447
• Report Number: 3010617000-2017-00235
• Device Sequence Number: 10887795
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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
• Operator of Device: Health Professional
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701-03
• Device Lot Number: 63423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1