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	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the product for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
As reported, during the first activation of the autopulse platform (sn (b)(4)), the device displayed user advisory - ua 12 (lifeband not present).No patient involvement.
Additional Manufacturer Narrative
The reported complaint of user advisory - ua12 (lifeband not present) error message on the autopulse platform (b)(4) was confirmed during device power on and archive data review.The lifeband switch clip does not closes and the lever not parallel to the switch case.It was determined that the root cause of error ua12 was due to misaligned lifeband switch clip.During visual inspection, no physical damage observed.During archive data review, error message ua12 (lifeband not present) was identified on the date of the reported complaint occurred.Thus, confirming the reported complaints.Initial functional testing could not be performed due to error message ua12 (not at "home" position after power-on/restart) displayed upon ap platform power on.Thus, confirming the reported complaint.To remedy the issue, the switch lever parallel to the switch case was realigned.The ap platform was re-tested and as expected, it passed all functional tests and ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse 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: 7760186
• Report Number: 3010617000-2018-00807
• Device Sequence Number: 1756853
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1