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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform displayed user advisory (ua) 17 (max motor on time exceeded during active operation) error message was confirmed during review of the archive data but was not confirmed during the initial functional testing.Analysis of the autopulse platform revealed no problems with the board which may have contributed to the reported complaint.Visual inspection was performed and noted no physical damages upon receipt.Archive review showed user advisory (ua) 17 error message on (b)(6) 2018, the platform stop compression six-time due to user advisory (ua) 17 error.Based on the platforms archive, li-ion battery (b)(4) had remain capacity (rc) 1422 mah, equivalent to about four green led's was used.The autopulse performed 36 compressions on a patient size fluctuating from small to medium during the failure.Initial functional testing was performed and passed with no error message.Further testing of the platform indicated that the drive train motor brake gap was within specification.The autopulse was subjected to the run in test using 95% patient large resuscitation test fixture and passed with no issue or faults observed.Historical complaints were reviewed and there was no previous history of complaints reported for the autopulse with serial number (b)(4).

Event Description

As reported, during patient use, the autopulse platform ((b)(4)) displayed user advisory (ua) 17 (max motor on time exceeded during active operation) error message.The customer tried to restart platform several times; however the error message persisted intermittently.Manual cpr was immediately performed.No additional information was provided.No patient consequence was reported.Date of event is unknown.

• 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7489176
• MDR Text Key: 107607296
• Report Number: 3010617000-2018-00517
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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