MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

It was noted that the fully charged li-ion battery (sn (b)(4)) was not holding a charge when placed in autopulse platform.No other information provided.No patient involvement was reported.Additional information received from the user stated that it is unknown when the issue was observed.The customer follows their regular battery rotation and ensures that the batteries are fully charged.Following the event, the batteries were tested in an autopulse multi chemistry charger and were able to successfully charge.

Manufacturer Narrative

The customer reported issue of the battery was not holding a charge and performed 3 compressions when placed in autopulse platform was confirmed during the functional testing and in archive review data.The root cause of the reported problem could not be determined however, a likely root cause for the battery failure based on the archive information can be due to damage or shorted component like a thermistor or resistor.In addition, battery has exceeded its expected service life of three years from its date of manufacture, (b)(4) 2014.Visual inspection noted no damage upon receipt.Three amber lights flashing were lit on incoming inspection.Archive showed on (b)(4) 2017 to the end of the archive, battery recorded multiple temperature mismatch errors on thermistor #0 close to fet and thermistor #2 close to battery cell #2.Battery capacity during the last error event is about 1003 mah equivalent to three amber lights on the battery status bar.Battery was last charged successfully on (b)(4) 2017 and was last inserted in the autopulse on (b)(4) 2017 without errors.The battery was tested in a good known multi chemistry charger and the battery failed to charge.

Event Description

It was noted that the fully charged li-ion battery (sn (b)(4) ) was not holding a charge and performed 3 compressions when placed in autopulse platform.No other information provided.No patient involvement was reported.Additional information received from the user stated that it is unknown when the issue was observed.The customer follows their regular battery rotation and ensures that the batteries are fully charged.Following the event, the batteries were tested in an autopulse multi chemistry charger and were able to successfully charge.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7102490
• MDR Text Key: 94982924
• Report Number: 3010617000-2017-01129
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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