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

Model Number	MODEL 100
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lifeband in complaint was returned to zoll on 05/18/2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
During patient use, the alignment tab of the lifeband (lot # 92272) got broken.The customer reported that the lifeband was in good condition before the alignment tab broke.However, the side of the lifeband, which was installed into the autopulse platform, showed excessive wear.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.
Additional Manufacturer Narrative
The lifeband (lot # 92272) was returned for evaluation; however, testing could not be performed due to the observed contamination.Moreover, the lifeband was cut by the customer prior to the return, and therefore, no further testing could be performed.Nevertheless, the reported complaint of "the alignment tab of the lifeband (lot # 92272) got broken" was confirmed based on the provided pictures from the customer.This type of damage can occur during user handling when the lifeband is not closed properly per user manual.Per autopulse system user guide, to properly align the two sides of the lifeband: place band 1 on top of patient's chest, locate mating slot of band 2 over the alignment tab 1, press the bands together to engage and secure the velcro fastener, lift up the lifeband to its fullest extension, ensuring that the side bands are at a 90 degree angle to the platform, that they are not twisted and that there are no obstructions and center the lifeband on the patient's chest, placing it such that its center is over the area upon which manual compressions are conducted.Failure to follow the above instructions results can damage or break the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for lifeband with lot # 92272.

• Brand Name: AUTOPULSE LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10101110
• Report Number: 3010617000-2020-00531
• Device Sequence Number: 3573545
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-08
• Device Lot Number: 92272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1