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)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the stitches near the belt clip of the lifeband (lot # 97059) were damaged, and the black plastic latch was broken" was confirmed during the visual inspection of the returned lifeband.The probable root cause for the damaged lifeband could be due to user mishandling.Upon visual inspection, it was observed that the stitches on the belt near the belt clip were separated, and it was also noted that the hinged belt guard of the lifeband was broken and completely detached; conditions typically attributed to user mishandling.As reported by the customer, "the lifeband (lot # 97059) was unable to be retracted, and the autopulse platform (sn: (b)(4)) displayed an unknown user advisory (ua) error message." the autopulse platform (sn: (b)(4)) was returned to zoll for evaluation, and investigation revealed that on the customer's reported event date, the platform displayed user advisory (ua) 18 (max take-up revolution exceeded) error message, which occurs when either the autopulse detects no weight present on the platform or when the lifeband remains opened.The observed physical damages of the returned lifeband may have resulted in the lifeband being improperly secured and/or open during use; thus, leading to the subsequent issue of the lifeband not being able to be retracted on the customer's reported event date.Functional testing could not be performed due to the observed lifeband damages.Historical complaints were reviewed for information related to the reported complaint, and there was no similar complaint reported for lifeband with lot# 97059.
Event or Problem Description
During training, the lifeband (lot # 97059) was unable to be retracted, and the autopulse platform (sn: (b)(4)) displayed an unknown user advisory (ua) error message.The customer reported that the lifeband was observed damaged on the stitches near the belt clip.It was also reported that the black plastic latch of the autopulse lifeband was broken.No patient involvement.As per the customer, a similar issue was observed on different user training sessions.Please see the following related mfr report: mfr # 3010617000-2020-01088 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: 10783117
• Report Number: 3010617000-2020-01112
• Device Sequence Number: 19782866
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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: 8700-0701-08
• Device Lot Number: 97059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1