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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lifeband associated with this complaint was discarded by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
As reported, the customer was unable to properly install the lifeband (lot # unknown) to the autopulse platform (sn: (b)(4)).When the lifeband was installed, it was loose and the clips did not stay-in-place during patient transport.As per the customer, the issue was observed with the autopulse platform during both shift checks and patient use, and different lifebands were tested; however, the same issue was observed.No error messages or fault codes observed on the platform.No consequences or impact to patient.Please see the following related mfr report: mfr # 3010617000-2020-01102 for the autopulse platform (sn: (b)(4)).

• Brand Name: AUTOPULSE LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10805935
• Report Number: 3010617000-2020-01103
• Device Sequence Number: 14372576
• Product Code: DRM
• UDI-Device Identifier: 00849111001601
• UDI-Public: 00849111001601
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 8700-0701-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1