MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation of the returned autopulse platform (sn (b)(4) on (b)(6) 2020, observed seized brake gap upon powering on.The root cause for the seized brake gap was due to the corrosion at the drive train motor brake housing area.This type of corrosive damage is indicative of either infrequent daily checks and/or indicative of storing the device in a location with high ambient humidity.Based on the archive, the routine shift check of the platform was not performed every day.Therefore, the probable root cause for the observed failure based on the review was due to user mishandling.Upon visual inspection, noticed a crack in the front-end area of the front enclosure and a crack near the battery bay on the bottom enclosure, likely attributed to mishandling.The front and bottom enclosure need to be replaced to address the physical damages.The autopulse platform passed the initial functional testing without any fault or error.However, upon powering on, there was no brake activation due to the corrosive damage.In addition, the archive data review showed occurrence of fault code 16 (timeout moving to take-up position).The brake assembly was seized from corrosion and this will contribute to the cause of fault code 16.The corrosion at the drive train motor brake housing area was removed using ipa (isopropyl alcohol).Performed brake gap inspection and verified the brake gap was within the specification of 0.008" ±0.001".Performed run-in test using the 95% patient test fixture (lrtf) with good known test batteries until discharged without any fault or error.The drive train motor will be replaced as a precautionary measure to address the fault code 16, as the drive train motor may have had some intermittent technical problems that could not be directly identified during the functional testing.Awaiting 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 sn (b)(4).
Event or Problem Description
During investigation of the returned autopulse platform (sn (b)(4) on (b)(6) 2020, observed seized brake gap upon powering on.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10992608
• Report Number: 3010617000-2020-01236
• Device Sequence Number: 869372
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (Y/N): N
• 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: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1