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

Model Number MODEL 100

Device Problems Activation, Positioning or Separation Problem (2906); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer primary report of the lifeband unable to retract during platform operation was not reproduced during functional testing of the autopulse platform (sn (b)(4)); however, review of the archive data revealed a user advisory (ua) 12 (lifeband not detected) error message occurring on (b)(6) 2017 and not on the customer reported event date of (b)(6) 2017, thus confirming the reported event.A possible cause for this issue is attributed to the improper installation of the lifeband in the platform.Visual inspection of the returned platform found a missing line on the user control panel due to a defective processor board.This observation is unrelated to the reported event.After replacement of the processor board, the platform was evaluated and found no other functional issue.The platform operated as intended and successfully performed continuous compressions using a large resuscitation test fixture without issue.Additionally, the secondary customer report of an internal sound observed on the platform during operation was not reproduced during functional testing.As a precautionary measure, the power distribution board was replaced to prevent this issue from reoccurring.The platform was then further tested without issue and met all specifications.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The ua 12 error message recorded in the archive data is easily clearable by the user.The ua 12 error message alerts the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.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 number (b)(4).

Event Description

It was reported that the autopulse platform (sn (b)(4)) was tested during shift check.The platform was powered on; however, the platform did not retract the lifeband when the user pressed the green button.Thus, the platform did not perform compression.Additionally, the reporter also reported internal noise coming out of the motor was also observed at the time of the event.No patient was involved.This report references the report of the platform unable to perform compression upon power up.The report of the lifeband unable to retract is referenced under mfr # 3010617000-2017-00813.

• 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: 6910792
• MDR Text Key: 88433915
• Report Number: 3010617000-2017-00786
• 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: 10/03/2017

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
• 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: 09/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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