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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During the deployment state, the user positioned the patient on the autopulse platform (sn (b)(4)) and placed the lifeband on the patient's chest; however, the user observed that the lifeband was unable to retract.Manual cpr was immediately performed for approximately 10 minutes until the patient achieved pulse.The length of troubleshooting was not specified.No further information was provided.No known patient consequences reported.Additional information received from the user stated that no issue was observed on the platform during shift check prior to the call.

Manufacturer Narrative

The customer reported issue of the autopulse "lifeband was unable to retract" message was not confirmed during the archive review and the initial functional testing.However, unrelated to the reported complaint, user advisory (ua) 41 (patient temperature sensor failure) error was displayed during platform testing.Temperature sensor was replaced to remedy the fault.Visual inspection was performed and found no physical damage to the autopulse platform.During functional testing, the platform displayed (ua) 41 upon powering up.Review of the archive data show no error messages occurred on the reported event date related to the "lifeband unable to retract", however, unrelated to the reported complaint, archive shows multiple user advisory (ua) 41 (patient temperature sensor failure) errors occurred on the same day.After repair, the autopulse was subjected to the 15 minutes run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of reported complaints for autopulse sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7795614
• MDR Text Key: 117589823
• Report Number: 3010617000-2018-00835
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• 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?: Yes
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1