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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn: (b)(4)) displayed ua45 (not at "home" position after power-on/restart) was confirmed based on the analysis of archive data.The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisories ua17 (max motor on time exceeded during active operation) and ua02 (compression tracking error)" and "the platform stopped compressions although the battery was at 2/3 of full charge" was confirmed based on the analysis of archive data and during functional testing.The root cause for the reported complaint was due to the defective drivetrain motor, which is usually attributed to normal wear and tear.The autopulse platform is a reusable device and was manufactured in december 2015, and it is reaching its serviceable life of 5 years.Visual inspection of the returned platform was performed and found no physical damages.The archive data review revealed that the autopulse platform was used to compress either patient/object on the customer's reported event date.A review of the archive data showed multiple occurrences of user advisories (ua) 02 (compression tracking error), (ua)17 (max motor on time exceeded during active operation), and (ua) 45 (not at "home" position after power-on/restart) error messages on the reported complaint date; thus, confirming the reported complaint.According to the archive, the autopulse platform stopped compressions multiple times due to ua17 and one time due to ua02.Based on the archive data, there was no malfunction for the battery that was used in the platform on the reported event date, and the battery functioned as intended.Ua17 will triggered when the autopulse did not reach target depth within the specification.The drive motor was on for more than 265ms during compression.The root cause for the observed user advisories was due to the defective drivetrain motor, which needs to be replaced to remedy the faults.The returned autopulse platform passed the initial functional testing without any fault or error.However, during the run-in test with large resuscitation testing fixture (lrtf), the platform repeatedly failed to continue compressions due to ua17 and ua02; thus, confirming the reported complaint.Waiting customer's approval for repair.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).
Event or Problem Description
During use of the loaner autopulse platform (sn: (b)(4)), the platform displayed the following user advisories: ua17 (max motor on time exceeded during active operation), ua45 (not at "home" position after power-on/restart), and ua02 (compression tracking error).The customer tried to adjust the lifeband to remedy the observed user advisories, but it was unsuccessful.Also, the platform stopped compressions although the lcd was displaying that the battery icon status was at 2/3 of full charge.Unknown if the platform was used on a patient or not.However, there is no report of consequences or impact to patient.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9969368
• Report Number: 3010617000-2020-00385
• Device Sequence Number: 3895950
• Product Code: DRM
• UDI-Device Identifier: 00849111000796
• UDI-Public: 00849111000796
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-08-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1