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

Model Number	8700-0701-03
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the autopulse lifeband in complaint for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
During patient use, the customer pressed the start button on autopulse platform (b)(4).; however, the unit froze and was displaying an error message "analyzing patient size".The platform also did not adjust the lifeband.The crew then reverted to manual cpr.No adverse consequences were reported.This is report for lifeband.For autopulse platform (b)(4) issue see mfr 3010617000-2018-00118.
Additional Manufacturer Narrative
The report autopulse platform displayed an error message "analyzing patient size" and did not adjust the lifeband was not confirmed based on the functional testing of returned lifeband.Visual inspection was performed and noted no damage upon receipt.In addition, unrelated to the reported issue, one of the hinged belt guards found to be slightly loose and does not produce a clicking sound.However, this observed issue does not affect the functionality of the lifeband.Functional testing was performed and the lifeband was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with the good test platform for 30 minutes and it function as intended.

• 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: 7214336
• Report Number: 3010617000-2018-00125
• Device Sequence Number: 16352276
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 8700-0701-03
• Device Catalogue Number: 8700-0701-03
• Device Lot Number: 71760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1