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

Model Number MODEL 100

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.

Event Description

The customer reported that the lifeband (lot #unknown) broke after performing 14 minutes of compressions during patient use.Following this, the crew immediately performed manual cpr.Per the customer, after replacing the lifeband, the autopulse platform was functional.No device malfunction was reported on the autopulse platform.No consequences or impact to the patient.

Event Description

The customer reported that the lifeband (lot # 140829) broke after performing 14 minutes of compressions during patient use to treat an 83-year-old male (82 kg) patient in cardiac arrest.Following this, the crew immediately performed manual cpr.Per the reporter, the patient was positioned properly on the platform and flat ground with no weird tension on the lifeband.Per the customer, after replacing the lifeband, the autopulse platform was functional.No device malfunction was reported on the autopulse platform.No consequences or impact to the patient.

Manufacturer Narrative

The reported complaint of the lifeband (lot # 140829) broke was confirmed during the visual inspection of the returned lifeband.The probable root cause for the broken lifeband was due to a manufacturing defect.Upon visual inspection, observed that the stitches on one side of the fold holding the breakaway link were missing, as a result, the breakaway link along with the band 1 got detached, thus confirming the reported complaint.In addition, noticed that the customer returned the lifeband without band 1 and band 2, most likely the customer cut the band 2 before returning the lifeband for evaluation.Also, unrelated to the reported complaint, noted one of the locking tabs of the lifeband cover was bent as a result of the user mishandling or due to the shipping damage as lifeband was packed into the small shipping box.No functional testing was performed due to the lifeband condition.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for lifeband with lot # 140829.Received additional information: a2-patient age, a3- patient sex, a4- patient weight, b5- describe event or problem, and d4- lot number.

• 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: 11984141
• MDR Text Key: 255656547
• Report Number: 3010617000-2021-00503
• 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: 07/15/2021

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: 8700-0701-01
• Device Lot Number: 140829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 82