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	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of the autopulse platform displayed user advisory (ua) 18 (max take-up revolutions exceeded) error message was confirmed during the archived review, but not during the initial functional testing.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, damaged front and bottom enclosures were noted.The front and bottom enclosure were replaced to address the issue.Review of the archive data indicated user advisory (ua) 18 errors occurred on the reported event date, thus confirming customer complaint.Note that user advisory error messages are designed into the platform when one of several conditions is detected.User advisory (ua) 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.Multiple run-in tests were performed, using the 95% patient large resuscitation test fixture (lrtf) simulating end take up and no faults or errors were observed.The autopulse passed all the testing and met all the required specifications.Historical complaints were reviewed for service information related to the reported complaint and there were no similar history of complaint reported for autopulse sn (b)(4).
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 18 (max take-up revolutions exceeded) error message.No patient involvement was reported.

• 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: 8476461
• Report Number: 3010617000-2019-00259
• Device Sequence Number: 13831912
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• Initial Reporter Country: NT
• 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
• Report Date (Section B): 04/02/2019

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1