MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE LI-ION BATTERY; LI-ION BATTERY, RECHARGEABLE

Model Number	MODEL 100
Medical Device Problem Code	Battery Problem (2885)
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
Zoll has not received the autopulse li-ion battery (sn (b)(4)) 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 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.The battery was manufactured on 7/27/2016 and is more than 4 years old.Zoll recommends the replacement of batteries that have exceeded their expected service life of 3 years.Please see the following related mfr reports: mfr 3010617000-2021-00080 for autopulse platform (sn (b)(4)).

• Brand Name: AUTOPULSE LI-ION BATTERY
• Common Device Name: LI-ION BATTERY, RECHARGEABLE
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11290324
• Report Number: 3010617000-2021-00099
• Device Sequence Number: 16322509
• Product Code: MOQ
• UDI-Device Identifier: 00849111001847
• UDI-Public: 00849111001847
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: D163369
• 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: 8700-0752-08
• 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