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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Fitting Problem (2183)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

The customer reported autopulse lifebands could not be secured in the back of the autopulse platform sn (b)(6).The lifeband does not line up with the clips.The customer tried two different lifebands with the same result.No device malfunction is suspected with the lifebands.No patient involvement.

Manufacturer Narrative

The reported complaint that autopulse lifebands could not be secured in the back of the autopulse platform sn (b)(6) was not confirmed during visual inspection or functional testing.The platform functioned appropriately and as intended.Zoll concluded that the root cause of the customer's reported complaint was related to an issue with the customer's lifeband.The lifeband returned with the platform was observed to be damaged, with a broken locking tab.However, the broken locking tab does not affect the functionality of the lifeband.During visual inspection, no physical damage was observed on the autopulse platform.The archive data review showed no significant discrepancies.The autopulse platform passed the initial functional testing without any fault or error.Following service, the autopulse platform passed the run-in test for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.

Manufacturer Narrative

B5 (describe event or problem) was corrected.

Event Description

The customer reported autopulse lifebands could not be secured in the back of the autopulse platform (sn (b)(6).The lifeband does not line up with the clips.Per the customer, the lifeband performed as intended in other platforms.The customer tried two different lifebands with the same result.No device malfunction is suspected with the lifebands.The platform was still able to perform compressions.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18611274
• MDR Text Key: 334142621
• Report Number: 3010617000-2024-00075
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2018
• 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