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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the patient call, the crew attempted to use the autopulse platform (sn unknown) on a patient but were unable to utilize the platform.The customer assumes an error message was displayed but is unsure.The crew did manual cpr before and after the attempt to use the platform.They did cpr for 25 min on site and another 25 min in the hospital.No impact or consequence to the patient was reported.After the code, the platform was examined, and the customer reported the plastic clip of the autopulse lifeband (lot unknown) was damaged inside of the gear shaft of the autopulse platform.Please see the following related mfr report: mfr #3010617000-2024-00262 for the autopulse lifeband.

Manufacturer Narrative

D4 (additional device information) was updated.The reported complaint that the autopulse platform sn (b)(6) could not be utilized, possibly due to an error message was confirmed during the archive review but not during functional testing.According to the archive, the platform displayed user advisory (ua) 02 (compression tracking error) around the event date.Based on the archive review, the device stopped compressions multiple times due to (ua) 02.The archive revealed that the take-up target and the max load sum exceeded 43 lbs, confirming that the size of the patient/object is too small and light in weight.The load sensors did not detect the expected increase in load during the compression.However, no device malfunction was observed during the functional testing and the autopulse platform performed as intended.The secondary complaint that the plastic clip of the autopulse lifeband (lot unknown) was damaged inside of the gear shaft of the autopulse platform was not confirmed during visual inspection or functional testing.During the service evaluation, no broken lifeband plastic clip was found inside the gear shaft.No issues were noted during testing and the platform performed as intended.Visual inspection of the returned platform was performed, and no physical damage was observed.A review of the archive data showed user advisory (ua) 02 (compression tracking error), related to the complaint.The autopulse platform passed the initial functional test without any fault or error.The reported complaint and (ua) 02 seen in the archive could not be reproduced.Load cell characterization was performed, and the results indicated that both load cells function within the specification.The platform was tested with the regular manikin using known good test batteries until discharged without any faults or errors.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.

• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19006060
• MDR Text Key: 338980319
• Report Number: 3010617000-2024-00261
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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