MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

The lifeband used at the time of the event will not be returned for evaluation, as it was discarded by the customer.Therefore, a physical investigation could not be performed and a root cause could not be determined.

Event Description

The autopulse platform (s/n (b)(4)) was used to resuscitate a hypothermic cardiac patient.The user reported that the platform performed compressions continuously for about 4 hours with no issues.Meanwhile, the battery was exchanged every 30 minutes to continue the compressions.After about 4 hours, the platform stopped compressions and displayed an unknown error message.It was noted that the lifeband (lot # unknown) had frayed away from the lifeband clips.Subsequently, the user powered off the autopulse and replaced the lifeband.However, the autopulse failed to power back on.Manual cpr was initiated immediately and continued for the rest of the code.Meanwhile, the autopulse was inspected, and it was noticed that there was blood dripping from the interior of the platform.The patient had multiple chest tubes in place, including one anterior for warming insertion and one lateral for drainage on each side.It was reported that the tubes had been dislodged, causing contaminated blood to enter the autopulse platform.The reason for the dislodgement of the tubes is unknown.No consequences or impact to the patient.Please see the following related mfr report: mfr # 3010617000-2021-00221 for the autopulse platform (s/n (b)(4)).

• Brand Name: AUTOPULSE LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11490416
• MDR Text Key: 244509492
• Report Number: 3010617000-2021-00289
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1