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

Model Number	MODEL 100
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During patient use, customer reported that lifeband was twisted intermittently on the autopulse platform (serial #(b)(4)) while operating and it displayed advisory (ua) 02 (compression tracking error) error message.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.The autopulse platform associated with this complaint is submitted under mfr 3010617000-2020-00487.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10037040
• Report Number: 3010617000-2020-00488
• Device Sequence Number: 11542403
• Product Code: DRM
• UDI-Device Identifier: 10849111002247
• UDI-Public: 10849111002247
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 05/07/2020

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: 8700-0706-14
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1