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

Model Number 8700-0702

Device Problems Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2016

Event Type  malfunction  

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.

Event Description

It was reported that during device check the autopulse platform (s/n (b)(4)) stopped compressions after a few compressions displaying a "low battery level" error.This was while using a known fully charge nimh battery (s/n (b)(4)).The customer tried two additional known fully charged nimh batteries (s/n's (b)(4)) with the same result.There was no patient involved with this event.Refer to mdrs 3010617000-2016-00143, 3010617000-2016-00145 and 3010617000-2016-00171.

Manufacturer Narrative

Three nickel metal hydride batteries (s/n (b)(4)) were returned to zoll (b)(4) for evaluation.Testing of the 3 batteries shows that the power on the 3 nimh batteries was below 1300 w indicating the battery's capacity is below its nominal run time and the battery should be exchanged with a fully charged battery.

• Brand Name: AUTOPULSE® NIMH 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: 5487087
• MDR Text Key: 39937008
• Report Number: 3010617000-2016-00144
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111002042
• UDI-Public: 00849111002042
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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
• Device Operator: Health Professional
• Device Model Number: 8700-0702
• Device Catalogue Number: 8700-0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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