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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operational Issue (2914)

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

Event Date 12/30/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (sn (b)(4)) was functionally tested and displayed a user advisory (ua) 12 (lifeband not present) during initial power on.The root cause for the ua 12 error messages is due to the lifeband switch assembly being out of specification.Review of the archive data confirmed the occurrence of ua 12 error messages on (b)(6) 2017.This is likely the device issue observed by the user on (b)(6) 2017, thus confirming the reported event.As part of routine service during testing, the platform was examined and found no physical damage and no other functional issue.The lifeband switch assembly was readjusted to specification and this resolved the ua 12 error message.The secondary issue of an observed grinding noise was not reproduced during evaluation.The device was further functionally tested and operated as intended without any fault or error observed.The device passed all final testing criteria.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial (b)(4).

Event Description

During patient use, the user reported that the autopulse platform (sn (b)(4)) malfunctioned and failed; however, the user was unable to specify details regarding the observed issue.Additionally, the user also observed that the device exhibited loud grinding noise during compression.Following this the user reverted to manual cpr.No error message was observed.No known impact or patient consequence was reported.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7226763
• MDR Text Key: 98865209
• Report Number: 3010617000-2018-00073
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• 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: 01/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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
• Patient Outcome(s): Hospitalization