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 Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

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.

Event Description

As reported, the autopulse li-ion battery (sn (b)(4)) does not hold charge.The user tested the battery in the autopulse platform and the platform did not power on.The autopulse platform powered on and functioned normally using other autopulse li-ion batteries.No consequences or impact to patient information was available.

Manufacturer Narrative

The reported event of "the autopulse li-ion battery (sn (b)(4)) does not hold charge" was confirmed during the archive data review but not during the functional testing.There were no device deficiencies found during the evaluation of the returned battery that could have caused or contributed to the reported complaint.The autopulse li-ion battery performed as intended.The root cause for the reported complaint was due to battery mismanagement and charging practice by the customer.Upon visual inspection, no physical damage was observed, and no leds of any type were lit on incoming inspection.The battery passed charging in a known good autopulse multi-chemistry charger (mcc).The battery remaining capacity was equivalent to four green lights on the battery status bar after charging attempt.The battery archive data review showed battery mismanagement and charging practice by the customer.The customer let the battery remain in the autopulse platform for an extended period of time and was discharged below its minimum operating voltage.The autopulse power system user guide states: "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery."a fully charged li-ion battery left in a zoll autopulse platform for an extended period of time will eventually discharge below its minimum operating voltage.A fully discharged battery will not display any led status lights and will fail charging.We noticed that battery was not maintained per user guide.Educated the customer by sending a letter with investigation findings and by providing a copy of the autopulse power system user guide.

• 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: 8485413
• MDR Text Key: 141018128
• Report Number: 3010617000-2019-00309
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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