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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the lcd screen of the autopulse platform (sn (b)(6)) was unreadable was not confirmed during functional testing and visual inspection.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.In addition, the customer reported a secondary issue with the damaged head restraint wire that was not confirmed during the visual inspection of the returned platform.Upon visual inspection, no physical damage was observed.The archive data review indicated multiple (ua) 18 (max take up revolution exceeded) error messages around the customer's reported event date, unrelated to the reported complaint.User advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per autopulse hangtag - advisory codes description and action, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.The autopulse platform passed the initial functional testing without fault or error.The lcd was clear and showed readable characters.The autopulse platform was power cycled multiple times and also tested with multiple batteries, and no problem was noted.Upon an internal inspection of the platform, the lcd board, pca board, and cable connector connections were checked with no issue found.The autopulse platform was further subjected to a run in test using the large resuscitation test fixture (lrtf) for 5 minutes, and the platform passed the testing without fault or error.In addition, the autopulse platform passed 15 minute run-in tests without fault or error.The autopulse platform passed the final testing without any fault or error.

Event Description

During the shift check, the lcd screen of the autopulse platform (sn (b)(6)) was unreadable.In addition, the head restraint wire was observed to be damaged.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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18726904
• MDR Text Key: 335753606
• Report Number: 3010617000-2024-00149
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/16/2024

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: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• 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