MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE LI-ION BATTERY; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.

Event Description

During the patient call, the autopulse platform performed the compressions with the fully charged battery, however, the battery capacity was depleted in 15 minutes.The platform powered off without displaying any error message.Per a reporter, the battery was charged 12 hours prior to the placement into the autopulse platform.Another battery was placed into the platform and performed the compressions without any issue.No known impact or consequence to patient information was provided.After the call, the autopulse platform and the same battery were tested with the manikin, the reported issue could not be reproduced by the user.The autopulse platform performed compressions for 45-50 minutes without any problem.See mfr 3010617000-2019-00820 for autopulse platform.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 9093622
• MDR Text Key: 159330907
• Report Number: 3010617000-2019-00821
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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