MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was not returned to zoll for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The customer reported that the autopulse li-ion battery s/n (b)(4) failed to power up the autopulse platform (s/n unknown) before their training session in (b)(6) 2021.The customer could not recall what led lights were illuminated on the battery before inserting it into the autopulse platform.However, the customer believed that the battery must have been successfully charged as the status led indicator on the charger showed a yellow led light during charging the battery, and a green led light was displayed after the charging was completed.The customer mentioned that they currently have no known-good li-ion batteries to test the autopulse platform to ensure whether the autopulse can power on and operate as intended.The customer provided no further information.No patient involvement.As per the customer, the battery was last successfully charged in (b)(6) 2021.Please see the following related mfr report: mfr # 3010617000-2021-00928 for the autopulse li-ion battery s/n (b)(4).

Event Description

The customer reported that the autopulse li-ion battery (s/n (b)(6)) failed to power up the autopulse platform (s/n (b)(6)) before their training session in (b)(6) 2021.The customer could not recall what led lights were illuminated on the battery before inserting it into the autopulse platform.However, the customer believed that the battery must have been successfully charged as the status led indicator on the charger showed a yellow led light during charging the battery, and a green led light was displayed after the charging was completed.The customer mentioned that they currently have no known-good li-ion batteries to test the autopulse platform to ensure whether the autopulse can power on and operate as intended.The customer provided no further information.No patient involvement.As per the customer, the battery was last successfully charged in (b)(6) 2021.Please see the following related mfr report: mfr # 3010617000-2021-00928 for the autopulse li-ion battery (s/n (b)(6)).

Manufacturer Narrative

The customer received new replacement autopulse li-ion batteries from zoll.The batteries were successfully charged and placed into service.The customer tested the autopulse platform (s/n (b)(6)) with the replacement batteries, and the autopulse platform performed as intended without issues, confirming the reported complaint was entirely caused by the failed battery.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12552287
• MDR Text Key: 274012816
• Report Number: 3010617000-2021-00946
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1