MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
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 lifeband (lot # 97059) was unable to be retracted, and the autopulse platform (sn: (b)(4)) displayed an unknown user advisory (ua) error message" was confirmed during the archive data review.The archive showed user advisory (ua) 18 (max take-up revolution exceeded) to have occurred on the customer's reported event date.The error message could not be replicated during the functional testing.The probable root cause of the ua18 error is either that the autopulse detected no weight present on the platform or the lifeband was opened as a result of user error.The lifeband (lot# 97059) was returned to zoll for evaluation.Investigation revealed 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.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.There was no physical damage observed on the returned autopulse platform during the visual inspection.The archive data review showed multiple ua18 (max take-up revolution exceeded) error messages to have occurred on the customer's reported event date; thus, confirming the reported complaint.User advisory 18 occurs when the driveshaft has traveled past the maximum number of revolutions without detecting a patient/object.As take-up is performed (when the user pressed the start button), the driveshaft moved the lifeband past the maximum allowable take-up depth without detecting a patient/object, which would result in a load change at the load plate.The take-up position is achieved when the load plates sense an additional 6 lbs of load compared to the pre-take-up load.The ua18 is also observed when the autopulse platform detects that the patient's chest or the size of the object/manikin on the platform is too small while sizing the patient (take-up) or when the lifeband is open.Based on the archive, the user managed to clear the ua18 error messages.Unrelated to the customer's reported complaint, further review of the archive data showed that on (b)(6) 2020, the autopulse platform had performed 2 sessions of compressions (4 compressions and 5 compressions), and then the platform stopped and displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message between each session.A user advisory 17 error message is triggered when the motor is on for too long during active operation, and the autopulse platform does not reach the target depth within the specification.The probable root cause of the ua17 error message was the stiffness of the patient's chest.Based on the archive, the user managed to clear the ua17 error code, and the error was not replicated during functional testing.In addition, archive data review showed a fault code 27 (encoder fault (> 3000 rpm)) error message to have occurred on (b)(6) 2020, unrelated to the customer's reported complaint.The error message was cleared by the customer and was not reproduced during the functional testing.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per auto pulse user advisory list, fault code 27 error message alerts the operator that the driveshaft is rotating too fast at a speed higher than 1000 rpm.This typically occurs if the lifeband is being pulled up on too sharply or due to an internal component error and/or defective encoder.If there is no internal component failure detected, this error message can be cleared when the user press restart.The autopulse platform passed initial functional testing without any fault or error.The load cell characterization test confirmed both load cell modules are functioning within the specification.During further functional testing, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) equivalent to 280 lbs with good known test batteries without any fault or error, and therefore, the customer's reported complaint could not be replicated.Awaiting the customer's approval for repair.
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 # 3010617000-2020-01112 for the lifeband (lot # 97059).
Additional Manufacturer Narrative
During service and final functional inspection, it was discovered that the tone mute button did not function properly.Troubleshooting the problem determined that the processor board had a latent defect in the section that controls the mute switch functionality.The processor board was replaced to remedy the problem, which was unrelated to the customer's initial complaint.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10783142
• Report Number: 3010617000-2020-01088
• Device Sequence Number: 3798559
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1