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 Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform sn (b)(4) for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Event Description

It was reported that after unboxing, the new autopulse platform sn (b)(4) would not power on using multiple autopulse li-ion batteries.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(6) would not power on using multiple autopulse li-ion batteries" was confirmed during the functional testing.The root cause for the reported complaint was a damaged/broken rivet joint nuts of the battery cable connector holding the connector to the battery bay, likely attributed to mishandling or a defective component.Upon visual inspection, unrelated to the reported complaint, noticed a crack on the front enclosure at the front-end area.The root cause was likely attributed to mishandling.The functional testing of the autopulse platform could not be performed due to the observed damage on the battery cable connector.The battery connector was replaced to address the reported complaint.The customer received another new autopulse platform as a replacement.Therefore, the autopulse platform will be stored for future refurbishment sale order requests.

• 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: 12322299
• MDR Text Key: 266653200
• Report Number: 3010617000-2021-00720
• 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: 09/15/2021

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: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/14/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1