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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lifeband in complaint was not returned to zoll for investigation.Therefore, a physical investigation could not be performed and a root cause could not be determined.
Event or Problem Description
As reported, the lifeband (lot # unknown) was unable to be retracted on the autopulse platform (sn: (b)(4)).In addition, one of the head restraint wires was noted to be torn off.No further information was provided by the customer.Patient use information was requested, but no additional information was provided; therefore, patient use is unknown.Please see the following related mfr report: mfr # 3010617000-2021-00117 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: 11325116
• Report Number: 3010617000-2021-00120
• Device Sequence Number: 10960077
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-08
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1