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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the platform is returned and investigation has been completed.
Event or Problem Description
During biomed testing, the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 12 (lifeband not detected) error message after compression of mannequin between 1 to 2 minutes.No patient involvement.
Additional Manufacturer Narrative
The report of a user advisory (ua) 12 (lifeband not present) was confirmed based on the functional testing and archive data review of the autopulse platform (sn (b)(4).The root cause is due to the switch lever not being able to close as it is not parallel to the switch case.Visual inspection of the platform found damaged bottom cover and the drive shaft is exhibiting binding and resistance.These observations are not related to the reported event.The archive data was reviewed and contained a ua 12 error message.The platform was functionally tested and displayed a user advisory (ua) 12 (lifeband not detected) error message after a few compression.Following this, a lifeband clip detect switch inspection was performed where it was indicated that the switch lever is not able to close and is not parallel to the switch case, causing the ua 12 error message to occur.After readjustment of the switch lever and verification using a standard belt test clip aid, the platform was further tested and operated as intended without any further issue fault or error.After replacement of the bottom cover and cleaning of the clutch, the platform was further tested and passed all testing criteria and met all required specifications.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).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7692638
• Report Number: 3010617000-2018-00719
• Device Sequence Number: 1329953
• Product Code: DRM
• UDI-Device Identifier: 00849111001021
• UDI-Public: 00849111001021
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1