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	08/25/2020
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 device testing by biomed, the lifeband does not retract on the autopulse platform (serial #(b)(4).Stiff rotation of the driveshaft on the autopulse platform.No patient involvement.Please see the following related mfr report: mfr 3010617000-2020-00997 for the lifeband.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) stiff rotation of the driveshaft was confirmed during the functional testing.The root cause for the reported complaint was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The autopulse platform was manufactured in february 2015 and has reached it's service life of 5 years.Upon visual inspection, unrelated to the reported complaint, a cracked front enclosure was observed on the autopulse platform.The physical damage was likely attributed to user mishandling, such as a drop.The front enclosure was replaced to address this issue.The archive data review showed no discrepancies.The initial functional testing of the autopulse platform passed without any fault or error.During further functional testing, stiff rotation of the driveshaft on the platform was observed.The customer reported complaint of the lifeband does not retract was probably attributed to the stiff rotation of the drive shaft.Thus, confirming the reported complaint.Deburring of the clutch plate was performed to address this issue.After service repair completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The load cell characterization test passed.The autopulse platform passed all functional tests.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 PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10557376
• Report Number: 3010617000-2020-00955
• Device Sequence Number: 2670510
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1