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

Model Number 8700-0752-01

Device Problems Premature Discharge of Battery (1057); Contamination (1120); Device Displays Incorrect Message (2591)

Patient Problem Vomiting (2144)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

Complainant alleged that when the battery status led indicator was pressed, it showed that the battery was fully charged.However, after a few compressions were performed during patient use, the platform stopped and indicated that the battery was "dead" (depleted).The battery was replaced with a new one.At the same time this incident occurred, the patient vomited.The patient's vomit got into the battery compartment and possibly contaminated it.The autopulse then displayed a "misalignment error"message, therefore use of the autopulse platform was discontinued.Customer reverted to manual cpr (length of time not provided).No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Customer reported that the battery was in the autopulse unit for 12 hours.Customer also reported that on (b)(6) 2014, an attempt was made to insert the same battery into the autopulse platform, however the "dead battery" (depleted battery) message appeared again.Customer also specified that they had intermittently observed this during earlier shift checks, whereby the battery status led would indicate that it was fully charged, however the autopulse indicated that it was "dead" (depleted).Customer also reported that the digital display was flickering and the "anti skid treads" were coming off the platform.Product in complaint was returned to zoll circulation on (b)(6) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.Please see the following related mfr report: #3003793491-2014-00196 autopulse platform with sn 31275r.

Manufacturer Narrative

The battery was returned and evaluated.Archive analysis results revealed that the battery was not charged for 28 days or more.It should also be noted that the autopulse platform archive was evaluated under related mfr # 3003793491-2014-00196 and found that li-ion battery (s/n (b)(4)) was used with the platform on the reported event date and did not have the proper number of test cycles at this time.The number of test cycles obtained for the battery was 7 cycles.The expected number of test cycles, based on a manufacturing date of april 2013, should have been 11 (+/- 1).Based on these results, the reported complaint was confirmed; the archive data is consistent with improper battery management which would lead to the reported failure of the platform displaying a "dead battery" message.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3757971
• MDR Text Key: 4415794
• Report Number: 3003793491-2014-00195
• 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: 03/26/2014

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: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• 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
• Treatment: MANUAL CPR
• Patient Age: 51 YR