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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" error message.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive data review.The root cause of the error message was due to the brake gap out-of-specification in which is likely attributed to normal wear and tear.The autopulse platform was manufactured in june 2009 and is more than 12 years old, well past its expected serviceable life of 5 years.During the visual inspection, a cracked top cover, front, and bottom enclosures, and the battery bay were observed, unrelated to the reported complaint.These types of physical damages were likely attributed to user mishandling such as a drop.The top cover, front, and bottom enclosures, and the battery bay were replaced to address the issue.During initial functional testing, the returned autopulse platform displayed a "system error, out of service, revert to manual cpr" error message, thus confirming the reported complaint.Also, unrelated to the reported issue, observed intermittent communication to the processor board during the retrieving of the archive log likely due to normal wear and tear.The processor board needs to be replaced to remedy the problem.During the archive data review, a system error 139 (unable to hold compression position) message was noted, thus confirming the reported complaint.The motor brake gap inspection test revealed that the drive train motor brake gap was out-of-specification, which caused system error 139.The bake gap could not be adjusted requiring the replacement of the defective drive train motor.Waiting for customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with a serial number (b)(6).

• 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: 12186030
• Report Number: 3010617000-2021-00617
• Device Sequence Number: 16845758
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1