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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

The customer reported that the locking tabs on the cover plate of the lifebands with lot #181831 do not snap into the autopulse platform's slots and can fall out easily with a gentle tug.The customer had to secure the lifeband to the autopulse platform using adhesive tape.Per the customer, the reported problem was noted while using the lifebands with autopulse platforms (sn (b)(6) and (b)(6)).No device malfunction was reported on the autopulse platforms.No patient involvement.

Manufacturer Narrative

Zoll has not received the lifebands with lot #181831 for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.

Event Description

The customer reported that the locking tabs on the cover plate of the lifebands with lot #181831 do not snap into the autopulse platform's slots and can fall out easily with a gentle tug (the same force when repositioning the device).The customer had to secure the lifeband to the autopulse platform using adhesive tape.The customer noted the reported problem while using the lifebands with the zoll loaner autopulse platforms (sn (b)(6) and (b)(6)).No patient involvement.Zoll personnel visited the customer site and tested the lifebands with lot #181831 with the zoll loaner autopulse platforms (sn (b)(6) and (b)(6)), and the reported issue persisted.The loaner autopulse platforms were tested with other lifebands, and the issue persisted.Please see the following related mfr report: mfr 3010617000-2024-00022 for the autopulse platform (sn (b)(6)).Mfr 3010617000-2024-00024 for the autopulse platform (sn (b)(6)).

Manufacturer Narrative

The customer's complaint that the locking tabs on the cover plate of the lifeband (lot # 181831) do not snap into the autopulse platforms (sn (b)(6)) slots and can fall out easily with a gentle tug was not confirmed during the testing at zoll.The lifeband functioned as intended using the know-good autopulse platform.The reported complaint's root cause was the out-of-specification die-cast channel.The autopulse platforms used during the reported event were manufactured in 2011 and 2012 and have an old version of the die-cast channel with wide dimensions, whereas the lifeband used during the event was manufactured in 2022 and has a lifeband cover plate dimension that fits the new version of the die-cast channel.This out-of-specification issue was limited to the autopulse platforms produced years ago between 2011 and 2012 and was corrected with a design change.Upon visual inspection, no physical damage was noted.The lifeband passed the functional testing with no issues.

• 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: 18271825
• MDR Text Key: 329808297
• Report Number: 3010617000-2023-01048
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 03/08/2024

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: 8700-0701-01
• Device Lot Number: 181831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 02/14/2024
• Supplement Dates FDA Received: 01/05/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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