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	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the patient use, the customer tested the autopulse platform with another autopulse li-ion battery and the platform performed compressions without any fault or error.Since there is no device malfunction observed, the customer will not be returning the autopulse platform to zoll for evaluation.The root cause for the reported issue based on the customer provided information was due to the battery problem.
Event or Problem Description
During the patient use, the autopulse platform (sn (b)(4)) stopped performing compressions and powered off by itself.There were no user advisories displayed on the platform.The manual cpr was performed during the troubleshooting.No consequences or impact to patient.The user observed the autopulse li-ion battery (sn (b)(4)) status as flashing green lights before it was placed into the platform.The platform was tested later on with a good known battery and functioned appropriately and as intended.The battery (sn (b)(4)) was placed in another platform and the reported issue was duplicated.Please see the following related mfr report: mfr 3010617000-2021-00099 for autopulse li-ion battery sn (b)(4).

• 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: 11290327
• Report Number: 3010617000-2021-00080
• Device Sequence Number: 715555
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 02/06/2021

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: 8700-0740-11
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1