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	11/12/2020
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.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 initial functional testing and archive data review.The root cause for (ua) 07 was a defective load cell.The cracked enclosures and defective load cell were likely attributed to mishandling such as a drop.During the visual inspection, a cracked front and bottom enclosures and bent battery lock were noted.The observed physical damages were unrelated to the reported complaint and likely attributed to user mishandling such as a drop.The front and bottom enclosures, and the battery lock were replaced to remedy the observed damage.Also, unrelated to the reported issue, a stiff manual rotation of the driveshaft was observed on the returned autopulse platform.This type of stiff rotation of the driveshaft issue is likely due to normal wear and tear.The returned autopulse platform was manufactured in june 2009 and it is more than 11 years old, well beyond the expected service life of 5 years.The clutch area was cleaned to remedy the driveshaft issue.In addition, unrelated to the reported complaint, noticed torn load plate cover.The probable root cause for the observed physical damage was user mishandling.The load plate cover was replaced to address the damage.The autopulse platform failed the initial functional testing due to user advisory (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 1 exceeds normal parameters and was replaced to remedy the (ua) 07 error.A review of the archive data showed (ua) 07 error messages to have occurred around the customer's reported event date, thus confirming the reported complaint.After the service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.A load cell characterization check was performed and confirmed that both load cell modules are functioning within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse 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: 10963988
• Report Number: 3010617000-2020-01225
• Device Sequence Number: 11307241
• 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): 04/18/2021

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: 11/18/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 04/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1