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

Model Number 8700-0752-01

Device Problem Charging Problem (2892)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse li-ion battery was not holding a charge.Customer reported that the led's on the battery indicated that the battery was fully charged.When the battery is placed into the charger, an amber light is illuminated, indicating that the battery is being charged.However, when the battery is then placed into the autopulse platform, the platform indicates that the battery does not have enough power.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse battery in complaint was returned to zoll on 05/08/2015 for investigation.Investigation results as follows: the customer's reported event was confirmed.The unit was charged at full capacity and tested with an autopulse platform.The fully charged battery did not power on the platform.The battery's archive data revealed that the date and time reset and therefore it could not be confirmed whether or not the unit was used on the reported date of (b)(6) /2015.The archive data was overwritten by error messages pertaining to internal battery communications on the backside bus and lost track of its history.Since the date and time could not be retrieved, battery management history could not be reviewed.The root cause of the failure is inconclusive and cannot be determined.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4659519
• MDR Text Key: 5598458
• Report Number: 3010617000-2015-00205
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• 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: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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