MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE LI-ION BATTERY; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.Please see the following related mfr reports: mfr # 3010617000-2019-00212 for the autopulse platform, mfr # 3010617000-2019-00222 for the 1st autopulse li-ion battery.

Event Description

As reported, during patient use, the autopulse platform powered off by itself for four times.Immediately the crew reverted to manual cpr.During the issue, the patient was on the stretcher in the elevator and transported to the hospital by ambulance.The patient was securely strapped to the platform using the shoulder straps during the transport.Per user, the platform didn't show any error message.Per user, when the crew paused the platform to check patient's pulse, the platform reverted to 30:2 compressions automatically.During the incident the crew used two autopulse li-ion batteries, the first battery status indicator showed three green led's on and the second battery status showed four green led's on.Per user, the patient was obese.No known impact or consequence to patient information was available.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8392904
• MDR Text Key: 138088394
• Report Number: 3010617000-2019-00223
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

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
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2019
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1