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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The zoll autopulse platform was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, during device setup for patient use, the autopulse platform displayed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message.The customer was unable to clear the error.No known impact or patient consequence information was provided.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during initial functional testing and archive data review.To remedy the issue, the driveshaft was rotated back to the home position.The likely root cause of the issue was due to user error.Per the autopulse user guide instruction, to clear user advisory (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.The autopulse platform passed functional test after drive shaft was rotated to the home position.Visual inspection was performed and found damaged top cover and the front enclosure as a result of user mishandling.To remedy the damage, the top cover and the front enclosure need to be replaced.The autopulse platform is a reusable device.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.The archive data review indicated multiple error message user advisory (ua) 45 on the reported event date.The platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient with good known test batteries for 15 minutes and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform 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: 9527685
• MDR Text Key: 179286538
• Report Number: 3010617000-2019-01155
• 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: 01/29/2020

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: 12/19/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1