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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.Date of event is unknown.
Event or Problem Description
During the device check, the autopulse platform (sn (b)(4) ) displayed user advisory (ua) 02 (compression tracking error) message several times.No patient involvement.
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform (sn (b)(6) displayed an error message user advisory (ua) 02 (compression tracking error) was confirmed during the load cell characterization test and archive data review.The root cause for the user advisory (ua) 02 error was due to defective load cell modules.The cracked front enclosure and defective load cells were likely attributed to mishandling such as a drop.Upon visual inspection, noticed a cracked front enclosure.The observed damage appeared to be the characteristics of user mishandling such as a drop.The front enclosure was replaced to remedy the observed issue.Also, found the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.This type of drive shaft issue is characteristic of normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate needs to be performed to remedy the encoder driveshaft issue.The autopulse platform is a reusable device and was manufactured in january 2008 and is more than 12 years old, well beyond the expected service life of 5 years.A review of the archive data indicated the error message user advisory (ua) 02 around the customer reported event date, thus confirming the reported complaint.Also, the archive shows the presence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message as it is related to the defective load cell issue.The load cell characterization test revealed that both of the load cells exceed normal parameters.The load cells were replaced to address the user advisory (ua) 02 error.The platform was further examined and unrelated to the reported complaint, it was noted that the power distribution board (pdb) revision level was below 6 and needed to be updated, attributed to the age of the platform.Following the repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with 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: 11883040
• Report Number: 3010617000-2021-00441
• Device Sequence Number: 3400007
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1