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 Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "autopulse li-ion battery (sn: (b)(4)) was stuck in the battery compartment of the autopulse platform" was confirmed during visual inspection of the returned battery.The root cause for the reported complaint was due to the damaged/chipped guide pins on the battery, attributed to user mishandling.Upon visual inspection, no physical damage was observed, and no leds of any type were lit upon incoming inspection.Unrelated to the reported complaint, the battery finger latch was observed damaged and stiff, possibly due to user handling.During functional testing, the battery passed charging in a known good autopulse multi-chemistry battery charger (mcc), and four green leds were lit after the successful charging attempt.
Event or Problem Description
During patient use, the autopulse platform (sn: (b)(4)) stopped functioning and turned off after performing a few compressions.In addition, the customer reported that autopulse li-ion battery (sn: (b)(4)) was stuck in the battery compartment of the autopulse platform.As per the customer, there were no breakages observed on either the battery finger latch or on the autopulse battery compartment.No consequences or impact to the patient.Please see the following related mfr report: mfr # 3010617000-2020-00622 for the 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
• MDR Report Key: 10172192
• Report Number: 3010617000-2020-00623
• Device Sequence Number: 11378014
• Product Code: MOQ
• UDI-Device Identifier: 00849111001854
• UDI-Public: 00849111001854
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: D163369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1