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	Insufficient Information (4580)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 21 (position change does not coincide with motor direction) error message" was not confirmed in the archive data and during functional testing.The probable cause or may have contributed to the reported ua21 error message could not be determined.Upon visual inspection, unrelated to the reported complaint, crack short and big black covers of the platform were observed.The observed physical damages appeared to be characteristic of user mishandling the short and big black coversr need to be replaced to address the observed physical damages.The archive data review indicated no ua21 error message; thus, not confirming the reported complaint.Further review of the archive data revealed multiple occurrences of fault code 16 (timeout moving to take-up position), ua17 (max motor on time exceeded during active operation), and ua20 (position out of range) error messages, unrelated to the reported complaints.The fault code 16, ua17 and ua20 errors was due to a defective drive train.The autopulse platform failed the initial functional test due to fault code 16 displayed during take-up, unrelated to the reported complaint.While powering on the autopulse platform, there was no brake activation.The root cause of fault code 16 error was due to defective drive train, likely attributed to an aging device.The autopulse platform was manufatured in january 2014 and is 8 years old, past its service life of 5 years.The drive train motor need to be replaced to address this error.Waiting on customer's approval for service repair.
Event or Problem Description
The customer reported that the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 21 (position change does not coincide with motor direction) error message.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15283395
• Report Number: 3010617000-2022-01203
• Device Sequence Number: 20596549
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown