MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Retraction Problem (1536); Visual Prompts will not Clear (2281)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

The customer reported that during shift check, the lifeband did not retract due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) displayed upon powering on the autopulse platform (sn (b)(4).No patient involvement.

Manufacturer Narrative

The customer reported a complaint that "the lifeband did not retract due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) displayed upon powering on the autopulse platform (sn (b)(4) was confirmed during the functional testing and archive data review.The root cause of the customer-reported complaint was a defective load cell, likely due to a defective component or mishandling such as a drop.Upon visual inspection, no physical damage was observed.The archive data indicated several ua07 errors around the reported event date, thus, confirming the customer's reported complaint.The autopulse platform failed initial functional testing due to ua07 displayed upon powering on, thus, confirming the customer's reported complaint.The load sensing system of the device has detected a weight/load imbalance between the two load cells.The load cell characterization result indicated that the single point load cell module 2 exceeded the normal parameters and will affect the linearity of the two load cells installed in the autopulse platform.The single-point load cell module 2 will be replaced to address the reported complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: 15366608
• MDR Text Key: 301987960
• Report Number: 3010617000-2022-01486
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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