MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the investigation has been completed.

Event Description

During shift check, the autopulse platform (sn (b)(4)) failed to power on.The customer tested the autopulse platform with multiple good working li-ion batteries, and the reported issue persisted.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(6) failed to power on using multiple good working autopulse li-ion batteries" was confirmed during the visual inspection.The root cause for the customer-reported complaint was a damaged battery cabling connector, likely attributed to a defective component.There was no other physical damage observed during the visual inspection.The functional testing of the returned autopulse platform could not be performed due to the observed damaged battery cabling connector.The battery cable was replaced to address the customer's reported complaint.A load cell characterization test was performed and confirmed that both cell modules function within the specification.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Unrelated to the reported complaint, the archive data review indicated ua02 (compression tracking error) and ua18 (maximum take-up depth exceeded) error messages.User advisory is a clearable error message; per the battery hangtag - advisory codes description and action, user advisory 2 indicates 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 for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.User advisory 18 indicates 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.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12292020
• MDR Text Key: 265560063
• Report Number: 3010617000-2021-00682
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1