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

Model Number MODEL 100

Device Problem Connection Problem (2900)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint that the lifeband was not staying secured to the autopulse platform (sn (b)(6)) was not confirmed during the functional testing.No device malfunction was observed, and the autopulse platform passed the testing with multiple lifebands at zoll.The autopulse platform functioned as intended.The lifeband used during the reported event was not returned to zoll for investigation.Upon visual inspection, no physical damage was noted.The autopulse platform passed the functional testing, and the archive data review showed no significant discrepancies.It was checked and verified when the lifeband cover plate was snapped in place by fully inserting the locking tabs into the slots on the autopulse platform.Flip down and snap into place the hinged skirts of the lifeband cover plate to engage the lifeband chest bands to the rollers.The lifeband belt clip locks correctly and securely in the drive shaft were checked and verified.Checked and verified the belt retainer compresses and releases freely.The platform was tested with the large resuscitation test fixture (lrtf) with well-known test batteries until discharged without fault or error.The autopulse platform functioned appropriately and performed as intended.The customer's complaint was not replicated, and the platform functioned as intended throughout the testing at zoll.Following service, the autopulse platform passed the run-in and final tests without fault or error.

Event Description

Upon installation during the shift check, the customer reported that the lifeband (lot #unknown) was not staying secured to the autopulse platform (sn (b)(6)).The lifeband gets disconnected upon pull-up/retraction.The platform did not show any user advisory or fault codes.There was no patient involvement.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18963506
• MDR Text Key: 338432067
• Report Number: 3010617000-2024-00240
• 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: 03/22/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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