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

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery associated with this complaint was not returned for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

It was reported that the autopulse lithium-ion battery (sn (b)(4)) was placed in the autopulse platform for patient use.Autopulse platform powered off after 30 seconds.According to the reporter, a fully charged battery was placed into the platform in less than 24 hours prior to being used at the time of the event.Another battery was placed and the platform operated as expected.No patient consequence was reported.

Manufacturer Narrative

The customer reported complaint was not confirmed during archive review and initial functional testing.The battery is working as intended for use.No physical damage and four green leds were illuminated when the status button was pressed during visual inspection.During functional testing, the battery was tested by inserting into a good known reference autopulse multi-chemistry charger (mcc) and was able to successfully charge with the battery illuminating four green leds on the battery status indicating that the battery is fully charged.The battery was tested with known good autopulse platform using the large rtf, performing compressions to specification and passing the functional test without any errors.The battery archive was downloaded and reviewed.The customer let the battery stay in the autopulse platform multiple times for an extended period of time which causes the battery to deplete down to a low voltage.In addition, the archive data show the battery was pulled out from the charger during the conditioning cycle.The autopulse power system user guide states that "a test-cycle can take up to 10 hours.Never interrupt a test-cycle by removing the battery from the charger.A battery that initially fails a test-cycle will automatically undergo additional test-cycles.Up to three test-cycles may be performed until the battery is considered to have failed (red led).".

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8081062
• MDR Text Key: 127866654
• Report Number: 3010617000-2018-01184
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

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
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1