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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The autopulse platform (sn (b)(4)) stopped compressions multiple times after performing 7 to 10 compressions while resuscitating a cardiac arrest patient.The customer stated that, after each stop, the crew reset the autopulse platform by pulling the lifeband back to the neutral position.The crew also attempted to turn the device off, remove and change the battery, and then restart the device.Additionally, the customer stated that the autopulse platform displayed a "low battery" message despite a fully charged autopulse li-ion battery being placed in the autopulse platform at shift exchange just 36 hours prior.When the crew swapped the batteries, the crew tested the charge on the removed battery, and the status leds showed that the battery was fully charged.The crew reverted to manual cpr, and then another automated cpr device was used.No consequences or impact to the patient.Please see the following related mfr report: mfr #3010617000-2021-01284 for the autopulse li-ion battery.

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.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13119611
• MDR Text Key: 283480028
• Report Number: 3010617000-2021-01221
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• 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