MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported during patient use, there seemed to be an issue with the white retention disc of the autopulse platform (sn (b)(6)), where either it or in combination with the drive shaft, it is sheering off part of the autopulse lifeband (lot unknown) pin.With a new band, the platform will perform 2-3 compressions then show user advisory (ua) 12 (lifeband not present) error message.The crew did manual compressions while troubleshooting the device.Once it was obvious that the device was not going to work anymore, they switched to continuous manual compressions.Compressions were never paused more than a few seconds during the troubleshooting process.The pin of the lifeband could be removed from the driveshaft without depressing the disc.The second lifeband performed as intended in other platforms.No impact or consequence to the patient.Please see the following related mfr report: mfr #3010617000-2024-00032 for the autopulse platform.
Additional Manufacturer Narrative
The lifeband in the complaint was discarded by the customer and will not be returned for investigation.Therefore, a physical investigation will not be performed.
Event or Problem Description
The customer reported during patient use, there seemed to be an issue with the white retention disc of the autopulse platform (sn (b)(6)), where either the disc or the disc in combination with the drive shaft, is shearing off the belt clip of the autopulse lifeband (lot unknown).With a new band, the platform will perform 2-3 compressions then show user advisory (ua) 12 (lifeband not present) error message.The crew did manual compressions while troubleshooting the device.Once it was obvious that the device was not going to work anymore, they switched to continuous manual compressions.Compressions were never paused more than a few seconds during the troubleshooting process.The pin of the lifeband could be removed from the driveshaft without depressing the disc.The second lifeband performed as intended in other platforms.No impact or consequence to the patient.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18511106
• Report Number: 3010617000-2024-00065
• Device Sequence Number: 7056983
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown