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	05/19/2021
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 the shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message with a red led.In addition, the customer reported the driveshaft could not be turned manually and the platform cover was damaged.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and the archive data review.The root cause for (ua) 07 was due to a defective load cell module.The cracked top cover, front, and bottom enclosures, and defective load cell module were likely attributed to mishandling such as a drop.During visual inspection, the platform was examined and found a cracked top cover, front, and bottom enclosures, and battery bay, unrelated to the reported complaint.This type of physical damage found during visual inspection is characteristic of the user mishandling such as a drop.The top cover, front, and bottom enclosures, and battery bay need to be replaced to address the physical damage.Also, unrelated to the reported complaint, noticed a hole on the load plate cover that affects the watertight seal.The probable root cause for the observed physical damage was user mishandling.The load plate cover needs to be replaced to address the damage.In addition, unrelated to the reported complaint, noticed a head restraint wire was cut.The patient head restraint wire could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.Missing head restraints do not render the autopulse platform non-functional.The noted physical damage to the top cover appeared to be the characteristic of user mishandling.Also, unrelated to the reported complaint, noticed the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.The clutch plate needs to be deburred to address the sticky clutch problem.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.The returned autopulse platform was manufactured in june 2008 and it is more than 13 years old, well beyond the expected service life of 5 years.There were no documented report was found showing that regular preventative maintenance (pm) was performed since the device was acquired by the customer.The autopulse platform failed the initial functional testing due to (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization test results confirmed that load cell module 2 exceeds normal parameters and needs to be replaced to remedy the (ua) 07 error.Also, during functional testing, noticed missing pixels on the lcd screen.The lcd needs to be replaced to address the observed issue.The probable root cause for the observed lcd issue could be normal wear and tear or mishandling, such as drop, as indicated by the broken covers noticed during the visual inspection.During further testing the platform failed due to a fault code 27 (encoder fault (>3000 rpm)) error message, unrelated to the reported complaint.The encoder indicated that the driveshaft was turning too fast at a speed higher than 3000 rpm during compression, and therefore, the fault code 27 was triggered.The root cause was the defective integrated encoder gearbox likely due to wear and tear.The encoder gearbox needs to be replaced to remedy the fault.A review of the archive data showed multiple (ua) 07 error messages to have occurred around the customer's reported event date, thus confirming the reported complaint.Waiting for customer 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 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: 11988592
• Report Number: 3010617000-2021-00504
• Device Sequence Number: 19935633
• 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): 07/15/2021

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: 05/25/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/12/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1