MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY; CARDIAC CHEST COMPRESSOR

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed if 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 during the cardiac arrest.The platform performed the compressions during the patient use; however, per reporter, the running time was less then expected.No patient harm or consequences reported on this event.No additional information was provided.

Manufacturer Narrative

The reported event was confirmed during archive data review; however was not reproduced during functional testing of the autopulse lithium ion battery (sn (b)(4).A root cause was attributed to battery mismanagement.The battery was received with no physical damage, and four green leds illuminated on the battery status indicator.The battery was functionally tested by inserting into a good known reference mcc and was able to successfully charge.After charging, the battery illuminated four green led on the battery status indicator.The battery was also tested by inserting it in a good known reference autopulse platform using a large resuscitation test fixture.The platform performed continuous compressions for 40 minutes without any issue observed.Review of the retrieved archive data revealed that the battery was last successfully charged in the autopulse multi chemistry charger (mcc) on (b)(6) 2018.It was noted that two charging cancellations were recorded on (b)(6) 2018, the reported event date.The autopulse power system user guide states that "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 autopulse lithium 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 be able to charge in the mcc.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7948173
• MDR Text Key: 123691280
• Report Number: 3010617000-2018-01010
• 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: 10/29/2018

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: 10/09/2018
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1