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)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lifeband used at the time of the event will not be returned for evaluation, as it was discarded by the customer.Therefore, a physical investigation could not be performed and a root cause could not be determined.
Event or Problem Description
During the patient call, the autopulse platform (sn (b)(4)) stopped compressions unexpectedly three times with a blank lcd screen.The battery used during the call was fully charged and correctly inserted.During the incident, the crew member noticed that the lifeband's belt on the right side was slightly twisted and, per the reporter, be a possible cause for the platfrom's interruption.There were no user advisories displayed on the platform during the entire call and the platform worked without issues between the stops.The patient's status information was requested but the customer did not provide a response, therefore the patient's status is unknown.Please see the following related mfr reports: mfr 3010617000-2021-00070 for autopulse platform.

• 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: 11264475
• Report Number: 3010617000-2021-00071
• Device Sequence Number: 2590352
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1