MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the lifeband (lot # 88573) broke was confirmed during the visual inspection of the returned lifeband.The probable root cause for the broken lifeband could be due to latent material defect.Upon visual inspection, observed the lifeband's spreader-link got detached from the belt, thus confirming the reported complaint.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for lifeband with lot # 88573.

Event Description

The autopulse lifeband broke during first compression.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.

Event Description

On 25 oct 2019 we received additional information from the reporter, during patient use, the autopulse lifeband broke after first compression.Return of spontaneous circulation (rosc) was achieved and patient was transported to the hospital.Later at the hospital the patient expired.

Manufacturer Narrative

The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9220686
• MDR Text Key: 164095117
• Report Number: 3010617000-2019-00934
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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: 11/19/2019

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: 8700-0701-01
• Device Lot Number: 88573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR