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

Model Number MODEL 100

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During checking lifebands before treatment, the customer found the band clip and hinged belt guard of the two newly received lifebands (lot#190702) were broken.No patient involvement.

Manufacturer Narrative

The reported complaint was confirmed during a visual inspection of the returned autopulse lifeband.The lifeband band clip (belt clip) and one of the tabs of the hinged belt guards (skirts) were noted to be broken.These issues prevented the placement of the band clip into the autopulse platform's driveshaft and prevented the lifeband hinged belt guard from being snapped in place, confirming the reported complaint.The observed damage appeared to be an isolated instance of excessive force applied to the lifeband belt clip and hinged belt guard during the placement of the lifeband.During further inspection, the broken belt clip was removed from the belt and the combined length of the two pieces matched the dimensions of a known-good lifeband belt clip.No additional testing was performed due to the condition of the lifeband upon receipt.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot #190702.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18896190
• MDR Text Key: 337576504
• Report Number: 3010617000-2024-00257
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10849111002247
• UDI-Public: 10849111002247
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 8700-0706-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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