MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® NIMH BATTERY

Model Number	8700-0702
Medical Device Problem Codes	Arcing (2583); Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional 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.Since the device has not been returned to zoll as of the date of this submission, we are unable to determine the cause of the battery arcing.However, accidental contact between terminals and metal object is considered a use error.Zoll ships batteries with a protective non-conducting cap on the terminals.Also, the battery user guide (p/n 10762-001, section 5.2) includes a caution statement: "do not short the battery power leads.Electrical connection (short) between battery power leads on the connector permanently damages the battery and renders the battery inoperable".
Event or Problem Description
It was reported that the autopulse nimh battery (s/n (b)(4)) arced to a medical employee's metal button on their jacket.There was no report of injury to a person.No additional information was provided.
Additional Manufacturer Narrative
The autopulse battery was returned for evaluation.A visual examination found the battery connector badly burnt due to the reported arcing event.The reported event was confirmed and results from user handling.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Common Device Name: NIMH BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5522824
• Report Number: 3010617000-2016-00180
• Device Sequence Number: 10868737
• Product Code: DRM
• UDI-Device Identifier: 00849111002042
• UDI-Public: 00849111002042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2016

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
• Operator of Device: Health Professional
• Device Model Number: 8700-0702
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2016
• Supplement Report FDA Received Date: 05/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1