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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Event Description

The customer reported that the autopulse li-ion battery (sn unknown) is stuck in the autopulse platform sn (b)(6).No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

B5 (describe event or problem) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.H6 codes were updated.The reported complaint of the autopulse li-ion battery (sn (b)(6)) being stuck in the autopulse platform (sn (b)(6)) was confirmed during visual inspection.The battery was stuck and couldn't be removed from the returned platform.The root cause for the reported complaint was the damaged/ broken latch of the autopulse li-ion battery, likely caused by mishandling such as a drop.The broken latch on the battery would cause the battery to be "stuck" in the platform's battery compartment.Per the autopulse power system guide: do not force a connection if you cannot easily connect battery to either the battery charger or the autopulse platform.If the battery is damaged, do not attempt to place the battery into the autopulse platform.This can cause damage to the internal connector of the autopulse platform.During further visual inspection, no apparent physical damage was observed on the returned autopulse platform.A review of the archive data showed several user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), unrelated to the customer's reported complaint.The ua07 advisory messages were cleared.User advisory is normally a clearable error message, and it is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 is an indication that the patient is out of position, or the patient is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient movement, and press restart to clear the ua.During the preliminary functional testing, the autopulse platform did not power on due to the drained battery being stuck inside the compartment.The platform's battery compartment was removed to get the battery out.After removing the battery, the platform's battery compartment was reinstalled.Subsequently, the autopulse platform passed the initial functional testing without fault or error.Following service, the autopulse platform was subjected to run-in test(s) using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.

Event Description

The customer reported that the autopulse li-ion battery (sn (b)(6)) is stuck in the autopulse platform (sn (b)(6)).No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19038838
• MDR Text Key: 339322285
• Report Number: 3010617000-2024-00281
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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